| Primary | The Change in Average of the 3 Highest Visual Analog Scale (VAS) Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28 From Baseline to Cycle 6 | Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst). | All participants in Full Analysis Set (FAS) with assessment for this outcome measure | Posted | | Mean | Standard Deviation | mm | | Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00043.05± 23.58
- OG00134.97± 25.90
|
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| 2-way ANOVA model with treatment and pain strata (headache and pelvic pain) as factors | ANOVA | | 0.0024 | Comparison of EV/DNG vs. EE/NGM | F-statistic | 9.3218 | | | | | | | | | | | Superiority or Other (legacy) | | |
|
| Secondary | The Change From Baseline to Cycle 6 in the Number of Ibuprofen Tablets Used as Rescue Medication | Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 7 days (Day 22) before the first menstrual bleeding until Day 28 (normalized to a standard 28-day cycle). Treatment period: 7 days (Day 22) before the withdrawal bleeding (WB) of the 6th treatment cycle until Day 28 of the same cycle (normalized to a standard 28-day cycle). Number of tablets taken by each subject, and then the Mean and standard deviation (SD) derived. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Tablets | | From Baseline to Cycle 6 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | The Change From Baseline to Cycle 13 in the Number of Ibuprofen Tablets Used as Rescue Medication | Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 7 days (Day 22) before the first menstrual bleeding until Day 28 (normalized to a standard 28-day cycle). Treatment period: 7 days (Day 22) before the withdrawal bleeding (WB) of the 13th treatment cycle until Day 28 before the same cycle (normalized to a standard 28-day cycle). Number of tablets taken by each subject, and then the Mean and standard deviation ((SD) derived. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Tablets | | From Baseline to Cycle 13 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Other Hormone-related Symptoms During Cycle Days 22-28 | Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 22-28. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 22-28 before 1st menstrual bleeding (normalized to a 7-day period). Treatment period: cycle Days 22-28 before WB of 6th treatment cycle until (normalized to a 7-day period). Score difference min -7 (best), max 7 (worst). | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
|
| Secondary | Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Other Hormone-related Symptoms During Cycle Days 22-28 | Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 22-28. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 22-28 before 1st menstrual bleeding (normalized to a 7-day period). Treatment period: cycle Days 22-28 before WB of 13th treatment cycle (normalized to a 7-day period). Score difference min -7 (best), max 7 (worst). | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | Day 22-28 from Baseline to Day 22-28 from Cycle 13 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
|
| Secondary | Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During Cycle Days 1-21 | Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 1-21. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 1-21 before 1st menstrual bleeding (normalized to a 21-day period). Treatment period: cycle Days 1-21 before WB of 6th treatment cycle (normalized to a 21-day period). Score difference min -21 (best), max 21 (worst). | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | Day 1-21 from Baseline to Day 1-21 from Cycle 6 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
|
| Secondary | Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During Cycle Days 1-21 | Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 1-21. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 1-21 before 1st menstrual bleeding (normalized to a 21-day period). Treatment period: cycle Days 1-21 before WB of 13th treatment cycle (normalized to a 21-day period). Score difference min -21 (best), max 21 (worst). | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | Day 1-21 from Baseline to Day 1-21 from Cycle 13 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
|
| Secondary | Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During the Hormone-free Interval Cycle Days 27 to 28 for EV/DNG and Cycle Days 22 to 28 for EE/NGM | Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode (cycle Days 22-28). Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Score difference min -2 (best), max 2 (worst) for the estradiol valerate (EV)/dienogest (DNG) group and min -7 (best), max 7 (worst) for the ethinylestradiol (EE)/norgestimate (NGM) group. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | From Baseline to Cycle 6 (cycle Days 27 to 28 for EV/DNG and cycle Days 22 to 28 for EE/NGM, 28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
|
| Secondary | Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During the Hormone-free Interval Cycle Days 27 to 28 for EV/DNG and Cycle Days 22 to 28 for EE/NGM | Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode (cycle Days 22-28). Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Score difference min -2 (best), max 2 (worst) for the EV/DNG group and min -7 (best), max 7 (worst) for the EE/NGM group. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | From Baseline to Cycle 13 (cycle Days 27 to 28 for EV/DNG and cycle Days 22 to 28 for EE/NGM, 28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
|
| Secondary | Change From Baseline to Cycle 3 in the Average of the Three Highest VAS Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28 | Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst). | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | mm | | Days 22-28 from Baseline to Days 22-28 from Cycle 3 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Change From Baseline to Cycle 13 in the Average of the Three Highest VAS Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28 | Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst). | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | mm | | Days 22-28 from Baseline to Days 22-28 from Cycle 13 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Number of Days With Bleeding or Spotting in Reference Period 1 | Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | From Day 1 to Day 90 | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Number of Days With Bleeding or Spotting in Reference Period 2 | Reference Period 2 is defined as Day 91 to Day 180 during study treatment. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | From Day 91 to Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Number of Days With Bleeding or Spotting in Reference Period 3 | Reference Period 3 is defined as Day 181 to Day 270 during study treatment. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | From Day 181 to Day 270 | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Number of Days With Bleeding or Spotting in Reference Period 4 | Reference Period 4 is defined as Day 271 to Day 360 during study treatment. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | From Day 271 to Day 360 | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Number of Bleeding / Spotting Episodes in Reference Period 1 | Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes. (Episode is a set of days with bleeding/spotting) | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Episodes | | From Day 1 to Day 90 | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Number of Bleeding / Spotting Episodes in Reference Period 2 | Reference Period 2 is defined as Day 91 to Day 180 during study treatment. (Episode is a set of days with bleeding/spotting) | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Episodes | | From Day 91 to Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Number of Bleeding / Spotting Episodes in Reference Period 3 | Reference Period 3 is defined as Day 181 to Day 270 during study treatment. (Episode is a set of days with bleeding/spotting) | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Episodes | | From Day 181 to Day 270 | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Number of Bleeding / Spotting Episodes in Reference Period 4 | Reference Period 4 is defined as Day 271 to Day 360 during study treatment. (Episode is a set of days with bleeding/spotting) | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Episodes | | From Day 271 to Day 360 | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Mean Length of Bleeding / Spotting Episodes in Reference Period 1 | Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | From Day 1 to Day 90 | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Mean Length of Bleeding / Spotting Episodes in Reference Period 2 | Reference Period 2 is defined as Day 91 to Day 180 during study treatment. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | From Day 91 to Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Mean Length of Bleeding / Spotting Episodes in Reference Period 3 | Reference Period 3 is defined as Day 181 to Day 270 during study treatment. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | From Day 181 to Day 270 | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Mean Length of Bleeding / Spotting Episodes in Reference Period 4 | Reference Period 4 is defined as Day 271 to Day 360 during study treatment. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | From Day 271 to Day 360 | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Maximum Length of Bleeding / Spotting Episodes in Reference Period 1 | Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | From Day 1 to Day 90 | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Maximum Length of Bleeding / Spotting Episodes in Reference Period 2 | Reference Period 2 is defined as Day 91 to Day 180 during study treatment. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | From Day 91 to Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Maximum Length of Bleeding / Spotting Episodes in Reference Period 3 | Reference Period 3 is defined as Day 181 to Day 270 during study treatment. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | From Day 181 to Day 270 | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Maximum Length of Bleeding / Spotting Episodes in Reference Period 4 | Reference Period 4 is defined as Day 271 to Day 360 during study treatment. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | From Day 271 to Day 360 | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 1 | Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | From Day 1 to Day 90 | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2 | Reference Period 2 is defined as Day 91 to Day 180 during study treatment. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | From Day 91 to Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 3 | Reference Period 3 is defined as Day 181 to Day 270 during study treatment. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | From Day 181 to Day 270 | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 4 | Reference Period 4 is defined as Day 271 to Day 360 during study treatment. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | From Day 271 to Day 360 | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Number of Days With Spotting-only in Reference Period 1 | Reference Period 1 is defined as Day 1 to Day 90 during study treatment. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | From Day 1 to Day 90 | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Number of Days With Spotting-only in Reference Period 2 | Reference Period 2 is defined as Day 91 to Day 180 during study treatment. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | From Day 91 to Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Number of Days With Spotting-only in Reference Period 3 | Reference Period 3 is defined as Day 181 to Day 270 during study treatment. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | From Day 181 to Day 270 | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Number of Days With Spotting-only in Reference Period 4 | Reference Period 4 is defined as Day 271 to Day 360 during study treatment. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | From Day 271 to Day 360 | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Number of Spotting-only Episodes in Reference Period 1 | Reference Period 1 is defined as Day 1 to Day 90 during study treatment. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Episodes | | From Day 1 to Day 90 | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Number of Spotting-only Episodes in Reference Period 2 | Reference Period 2 is defined as Day 91 to Day 180 during study treatment. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Episodes | | From Day 91 to Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Number of Spotting-only Episodes in Reference Period 3 | Reference Period 3 is defined as Day 181 to Day 270 during study treatment. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Episodes | | From Day 181 to Day 270 | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Number of Spotting-only Episodes in Reference Period 4 | Reference Period 4 is defined as Day 271 to Day 360 during study treatment. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Episodes | | From Day 271 to Day 360 | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Mean Length of Spotting-only Episodes in Reference Period 1 | Reference Period 1 is defined as Day 1 to Day 90 during study treatment. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | From Day 1 to Day 90 | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Mean Length of Spotting-only Episodes in Reference Period 2 | Reference Period 2 is defined as Day 91 to Day 180 during study treatment. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | From Day 91 to Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Mean Length of Spotting-only Episodes in Reference Period 3 | Reference Period 3 is defined as Day 181 to Day 270 during study treatment. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | From Day 181 to Day 270 | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Mean Length of Spotting-only Episodes in Reference Period 4 | Reference Period 4 is defined as Day 271 to Day 360 during study treatment. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | From Day 271 to Day 360 | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Maximum Length of Spotting-only Episodes in Reference Period 1 | Reference Period 1 is defined as Day 1 to Day 90 during study treatment. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | From Day 1 to Day 90 | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Maximum Length of Spotting-only Episodes in Reference Period 2 | Reference Period 2 is defined as Day 91 to Day 180 during study treatment. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | From Day 91 to Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Maximum Length of Spotting-only Episodes in Reference Period 3 | Reference Period 3 is defined as Day 181 to Day 270 during study treatment. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | From Day 181 to Day 270 | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Maximum Length of Spotting-only Episodes in Reference Period 4 | Reference Period 4 is defined as Day 271 to Day 360 during study treatment. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | From Day 271 to Day 360 | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 1 | Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | From Day 1 to Day 90 | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2 | Reference Period 2 is defined as Day 91 to Day 180 during study treatment. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | From Day 91 to Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 3 | Reference Period 3 is defined as Day 181 to Day 270 during study treatment. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | From Day 181 to Day 270 | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 4 | Reference Period 4 is defined as Day 271 to Day 360 during study treatment. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | From Day 271 to Day 360 | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1 | Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. | All participants in FAS with assessment for this outcome measure | Posted | | Number | | Percentage of participants | | At Cycle 1 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3 | Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. | All participants in FAS with assessment for this outcome measure | Posted | | Number | | Percentage of participants | | At Cycle 3 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6 | Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. | All participants in FAS with assessment for this outcome measure | Posted | | Number | | Percentage of participants | | At Cycle 6 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Percentage of Participants With / Without Withdrawal Bleeding at Cycle 13 | Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. | All participants in FAS with assessment for this outcome measure | Posted | | Number | | Percentage of participants | | At Cycle 13 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Length of Withdrawal Bleeding Episodes at Cycle 1 | Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | At Cycle 1 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Length of Withdrawal Bleeding Episodes at Cycle 3 | Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | At Cycle 3 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Length of Withdrawal Bleeding Episodes at Cycle 6 | Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | At Cycle 6 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Length of Withdrawal Bleeding Episodes at Cycle 13 | Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | At Cycle 13 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1 | Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Scores on a scale | | At Cycle 1 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3 | Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Scores on a scale | | At Cycle 3 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6 | Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Scores on a scale | | At Cycle 6 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 13 | Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Scores on a scale | | At Cycle 13 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Onset of Withdrawal Bleeding Episodes at Cycle 1 | Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM). | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | At Cycle 1 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Onset of Withdrawal Bleeding Episodes at Cycle 3 | Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM). | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | At Cycle 3 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Onset of Withdrawal Bleeding Episodes at Cycle 6 | Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM). | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | At Cycle 6 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Onset of Withdrawal Bleeding Episodes at Cycle 13 | Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM). | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | At Cycle 13 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1 | Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. | All participants in FAS with assessment for this outcome measure | Posted | | Number | | Percentage of participants | | At Cycle 1 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3 | Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. | All participants in FAS with assessment for this outcome measure | Posted | | Number | | Percentage of participants | | At Cycle 3 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6 | Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. | All participants in FAS with assessment for this outcome measure | Posted | | Number | | Percentage of participants | | At Cycle 6 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 13 | Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. | All participants in FAS with assessment for this outcome measure | Posted | | Number | | Percentage of participants | | At Cycle 13 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Number of Intracyclic Bleeding Episodes at Cycle 1 | Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding) | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Episodes | | At Cycle 1 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Number of Intracyclic Bleeding Episodes at Cycle 3 | Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding) | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Episodes | | At Cycle 3 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Number of Intracyclic Bleeding Episodes at Cycle 6 | Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding) | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Episodes | | At Cycle 6 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Number of Intracyclic Bleeding Episodes at Cycle 13 | Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding) | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Episodes | | At Cycle 13 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Maximum Length of Intracyclic Bleeding Episodes at Cycle 1 | Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | At Cycle 1 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Maximum Length of Intracyclic Bleeding Episodes at Cycle 3 | Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | At Cycle 3 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Maximum Length of Intracyclic Bleeding Episodes at Cycle 6 | Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | At Cycle 6 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Maximum Length of Intracyclic Bleeding Episodes at Cycle 13 | Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | At Cycle 13 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Number of Intracyclic Bleeding Days at Cycle 1 | Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | At Cycle 1 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Number of Intracyclic Bleeding Days at Cycle 3 | Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | At Cycle 3 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Number of Intracyclic Bleeding Days at Cycle 6 | Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | At Cycle 6 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Number of Intracyclic Bleeding Days at Cycle 13 | Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Days | | At Cycle 13 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1 | Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy. | All participants in FAS with assessment for this outcome measure | Posted | | Number | | Percentage of participants | | At Cycle 1 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3 | Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy. | All participants in FAS with assessment for this outcome measure | Posted | | Number | | Percentage of participants | | At Cycle 3 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6 | Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy. | All participants in FAS with assessment for this outcome measure | Posted | | Number | | Percentage of participants | | At Cycle 6 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 13 | Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy. | All participants in FAS with assessment for this outcome measure | Posted | | Number | | Percentage of participants | | At Cycle 13 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
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| Secondary | Percentage of Participants With at Least 1 Intracyclic Bleeding Episode at Cycles 2 to 6 | Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. | All participants in FAS with assessment for this outcome measure | Posted | | Number | | Percentage of participants | | Cycles 2 to 6 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Percentage of Participants With at Least 1 Intracyclic Bleeding Episode at Cycles 2 to 13 | Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. | All participants in FAS with assessment for this outcome measure | Posted | | Number | | Percentage of participants | | Cycles 2 to 13 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
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| Secondary | Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) | Change from Baseline to Cycle 6 in PGWBI Questionnaire's assessment of participant's overall sense of well-being or distress. The PGWBI includes 22 items that, apart from combining into a global overall score, are divided into 6 dimensions: anxiety, depressed mood, positive well-being, self-control, health, and vitality. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score as well as all the sub-domains score ranges from -100 (worst) to 100 (best). | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline up to Cycle 6 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Mean Change From Baseline to Cycle 13 in Psychological General Well-Being Index (PGWBI) | Change from Baseline to Cycle 13 in PGWBI Questionnaire's assessment of participant's overall sense of well-being or distress. The PGWBI includes 22 items that, apart from combining into a global overall score, are divided into 6 dimensions: anxiety, depressed mood, positive well-being, self-control, health, and vitality. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score as well as all the sub-domains score ranges from -100 (worst) to 100 (best). | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline up to Cycle 13 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
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| Secondary | Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Physical Health | Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (physical health - 13 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best). | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline up to Cycle 6 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Physical Health | Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (physical health - 13 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best). | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline up to Cycle 13 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Participant Feeling | Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (participant feeling - 14 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best). | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline up to Cycle 6 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
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| Secondary | Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Participant Feeling | Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (participant feeling - 14 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best). | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline up to Cycle 13 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Work | Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (work - yes or no; if yes, then 4 choices, and 13 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best). | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline up to Cycle 6 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Work | Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (work - yes or no; if yes, then 4 choices, and 13 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best). | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline up to Cycle 13 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Household Duties | Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (household duties - yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best). | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline up to Cycle 6 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Household Duties | Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (household duties - yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best). | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline up to Cycle 13 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - School/Course Work | Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (school / course work - yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best). | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline up to Cycle 6 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
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| Secondary | Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - School/Course Work | Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (school / course work - yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best). | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline up to Cycle 13 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Leisure Time Activities | Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (leisure time activities - 6 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best). | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline up to Cycle 6 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Leisure Time Activities | Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (leisure time activities - 6 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best). | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline up to Cycle 13 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Social Relationship | Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (social relationship - 11 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best). | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline up to Cycle 6 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Social Relationship | Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (social relationship - 11 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best). | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline up to Cycle 13 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - General Activities | Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (general activities - 16 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best). | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline up to Cycle 6 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - General Activities | Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (general activities - 16 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best). | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline up to Cycle 13 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Item Satisfaction | Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (item satisfaction). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best). | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline up to Cycle 6 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Item Satisfaction | Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (item satisfaction). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best). | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline up to Cycle 13 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| |
| Secondary | Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Overall Life Satisfaction and Contentment | Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (overall life satisfaction and contentment). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best). | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline up to Cycle 6 (28 days per Cycle) | | | | ID | Title | Description |
|---|
| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
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| Secondary | Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Overall Life Satisfaction and Contentment | Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (overall life satisfaction and contentment). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best). | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline up to Cycle 13 (28 days per Cycle) | | | | ID | Title | Description |
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| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
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| Secondary | Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 6 | CGI is used to collect information regarding the subject's total clinical experience. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement. | All participants in FAS with assessment for this outcome measure | Posted | | Number | | Percentage of participants | | At Cycle 6 (28 days per Cycle) | | | | ID | Title | Description |
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| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
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| Secondary | Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 13 | CGI is used to collect information regarding the subject's total clinical experience. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement. | All participants in FAS with assessment for this outcome measure | Posted | | Number | | Percentage of participants | | At Cycle 13 (28 days per Cycle) | | | | ID | Title | Description |
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| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
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| Secondary | Percentage of Participants With Improvement in the Participant's Assessment in Clinical Global Impression (CGI) at Cycle 6 | In 1 section of the CGI the subject rates their total improvement and rate of satisfaction with sexuality during treatment. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement. | All participants in FAS with assessment for this outcome measure | Posted | | Number | | Percentage of participants | | At Cycle 6 (28 days per Cycle) | | | | ID | Title | Description |
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| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
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| Secondary | Percentage of Participants With Improvement in the Participant's Assessment in Clinical Global Impression (CGI) at Cycle 13 | In 1 section of the CGI the subject rates their total improvement and rate of satisfaction with sexuality during treatment. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement. | All participants in FAS with assessment for this outcome measure | Posted | | Number | | Percentage of participants | | At Cycle 13 (28 days per Cycle) | | | | ID | Title | Description |
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| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
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| Other Pre-specified | Percentage of Participants With no Increase in Rescue Medication and VAS Decrease During Cycle Days 22 to 28 From Baseline to Cycle 6 | Rescue medication was standardized intake of 200 mg Ibuprofen tablets. Baseline: 7 days (Day 22) before first menstrual bleeding to Day 28. Treatment: 7 days (Day 22) before withdrawal bleeding of 6th cycle to Day 28 before the same cycle. The visual analog scale (VAS) is a subject-assessed measure of pelvic pain or headache consisting of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst). | All participants in FAS with assessment for this outcome measure | Posted | | Number | | Percentage of participants | | Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle) | | | | ID | Title | Description |
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| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
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| Other Pre-specified | The Change of Pelvic Pain or Headache as Determined by the Highest Visual Analog Scale (VAS) Values During Cycle Days 22 to 28 From Baseline to Cycle 6 | Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst). | All participants in FAS with assessment for this outcome measure | Posted | | Mean | Standard Deviation | mm | | Days 22-28 from Baseline to Days 22-28 from Cycle 6 (28 days per Cycle) | | | | ID | Title | Description |
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| OG000 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | | OG001 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
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