| Primary | Serum Concentration of Prothrombin Fragments 1 + 2 | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. | All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6 | Posted | | Mean | Standard Deviation | nmol/L | | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
| | | Title | Denominators | Categories |
|---|
| Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | | | Title | Measurements |
|---|
| - OG0000.18± 0.20
- OG0010.19± 0.08
|
| | Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE) | | |
| | 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 |
|---|
| P-value compares the change from baseline to Cycle 6 between treatment groups. | Cochran-Mantel-Haenszel | Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline. | 0.0849 | No correction for multiple testing was made. | | | | | | 95 | | | | | | | Superiority or Other (legacy) | | |
|
| Primary | Serum Concentration of D-Dimer | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. | All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6 | Posted | | Mean | Standard Deviation | mg/L Fibrinogen Equivalent Units (FEU) | | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
| |
| Primary | Activated Protein C (APC) Resistance Ratio (Endogenous Thrombin Potential [ETP]-Based) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). APC resistance ratio (ETP-based) measures the anticoagulation response of plasma to APC after activation of the extrinsic coagulation pathway. An increase in the ratio indicates a reduced responsiveness to APC. Each cycle consists of 28 days. | All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6 | Posted | | Mean | Standard Deviation | Ratio | | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
| |
| Primary | Serum Concentration of Clotting Factor VIIa | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. | All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6 | Posted | | Mean | Standard Deviation | U/L | | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
| |
| Primary | Serum Concentration of Clotting Factor VIIc | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. | All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6 | Posted | | Mean | Standard Deviation | Percent of normal | | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
| |
| Secondary | Serum Concentration of Total Testosterone | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. | All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6 | Posted | | Mean | Standard Deviation | nmol/L | | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
| |
| Secondary | Serum Concentration of Free Testosterone | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. | All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6 | Posted | | Mean | Standard Deviation | pmol/L | | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
| |
| Secondary | Serum Concentration of Dehydroepiandrosterone Sulphate (DHEAS) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. | All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6 | Posted | | Mean | Standard Deviation | umol/L | | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
| |
| Primary | Serum Concentration of Clotting Factor VIII | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. | All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6 | Posted | | Mean | Standard Deviation | Percent of normal | | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
| |
| Primary | Serum Concentration of Clotting Factor II | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. | All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6 | Posted | | Mean | Standard Deviation | Percent of normal | | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
| |
| Primary | Serum Concentration of Antithrombin III | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. | All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6 | Posted | | Mean | Standard Deviation | Percent of normal | | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
| |
| Primary | Serum Concentration of Protein S (Free) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. | All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6 | Posted | | Mean | Standard Deviation | Percent of normal | | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
| |
| Primary | Serum Concentration of Protein S (Total) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. | All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6 | Posted | | Mean | Standard Deviation | Percent of normal | | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
| |
| Primary | Serum Concentration of Protein C | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. | All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6 | Posted | | Mean | Standard Deviation | Percent of normal | | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
| |
| Primary | APC Resistance Ratio (Activated Partial Thromboplastin Time [APTT]-Based) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). APC resistance ratio (APTT-based) measures the anticoagulation response of plasma to APC after activation of the intrinsic coagulation pathway. An increase in the ratio indicates a increased responsiveness to APC. Each cycle consists of 28 days. | All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6 | Posted | | Mean | Standard Deviation | Ratio | | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
| |
| Primary | Serum Concentration of Sex Hormone Binding Globulin (SHBG) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. | All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6 | Posted | | Mean | Standard Deviation | nmol/L | | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
| |
| Primary | Serum Concentration of C-Reactive Protein (CRP) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. | All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6 | Posted | | Mean | Standard Deviation | mg/L | | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
| |
| Primary | Serum Concentration of Total Cholesterol | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. | All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6 | Posted | | Mean | Standard Deviation | mmol/L | | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
| |
| Primary | Serum Concentration of High Density Lipoprotein (HDL)-Cholesterol | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. | All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6 | Posted | | Mean | Standard Deviation | mmol/L | | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
| |
| Primary | Serum Concentration of HDL2-cholesterol | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. | All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6 | Posted | | Mean | Standard Deviation | mmol/L | | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
| |
| Primary | Serum Concentration of HDL3-cholesterol | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. | All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6 | Posted | | Mean | Standard Deviation | mmol/L | | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
| |
| Primary | Serum Concentration of Low Density Lipoprotein (LDL)-Cholesterol | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. | All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6 | Posted | | Mean | Standard Deviation | mmol/L | | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
| |
| Primary | Serum Concentration of Apolipoprotein A-1 | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. | All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6 | Posted | | Mean | Standard Deviation | g/L | | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
| |
| Primary | Serum Concentration of Apolipoprotein B | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. | All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6 | Posted | | Mean | Standard Deviation | g/L | | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
| |
| Primary | Serum Concentration of Lipoprotein(a) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. | All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6 | Posted | | Mean | Standard Deviation | g/L | | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
| |
| Primary | Serum Concentration of Total Triglycerides | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. | All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6 | Posted | | Mean | Standard Deviation | mmol/L | | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
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| Primary | Area Under the Curve Over 3 Hours (AUC3) for Glucose (Oral Glucose Tolerance Test [OGTT]) | Blood glucose levels were determined as fasting values just before oral glucose intake and each half hour thereafter for 2 hours and again after 3 hours. Oral glucose tolerance was analysed using the (unadjusted) area under the curve over the 3 hours (AUC3). Each cycle consists of 28 days. | All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6 | Posted | | Mean | Standard Deviation | hrs*mmol/L | | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
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| Primary | Incremental AUC3 for Glucose (OGTT) | Blood glucose levels were determined as fasting values just before oral glucose intake and each half hour thereafter for 2 hours and again after 3 hours. Oral glucose tolerance was analysed using the (unadjusted) area under the curve over the 3 hours (AUC3). Incremental area under the curve was defined as incremental AUC3 = AUC3 - 3*fasting concentration. Each cycle consists of 28 days. | All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6 | Posted | | Mean | Standard Deviation | hrs*mmol/L | | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
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| Primary | AUC3 for Insulin (OGTT) | Blood insulin levels were determined as fasting values just before oral glucose intake and each half hour thereafter for 2 hours and again after 3 hours. Oral glucose tolerance was analysed using the (unadjusted) area under the curve over the 3 hours (AUC3). Each cycle consists of 28 days. | All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6 | Posted | | Mean | Standard Deviation | hrs*pmol/L | | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
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| Primary | Incremental AUC3 for Insulin (OGTT) | Blood insulin levels were determined as fasting values just before oral glucose intake and each half hour thereafter for 2 hours and again after 3 hours. Oral glucose tolerance was analysed using the (unadjusted) area under the curve over the 3 hours (AUC3). Incremental area under the curve was defined as incremental AUC3 = AUC3 - 3*fasting concentration. Each cycle consists of 28 days. | All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6 | Posted | | Mean | Standard Deviation | hrs*pmol/L | | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
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| Primary | Serum Concentration of Hemoglobin Type A1c (HbA1c) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). HbA1c was determined before glucose loading. Each cycle consists of 28 days. | All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6 | Posted | | Mean | Standard Deviation | Percent of glycosylated hemoglobin | | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
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| Primary | Serum Concentration of Total Cortisol | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. | All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6 | Posted | | Mean | Standard Deviation | nmol/L | | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
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| Primary | Serum Concentration of Corticosteroid Binding Globulin (CBG) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. | All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6 | Posted | | Mean | Standard Deviation | nmol/L | | Baseline to Cycle 6 (between Days 15 and 21 of the cycle) | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
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| Primary | Serum Concentration of Thyroid Stimulating Hormone (TSH) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. | All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6 | Posted | | Mean | Standard Deviation | mU/L | | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
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| Primary | Serum Concentration of Free Thyroxine (T4) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. | All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6 | Posted | | Mean | Standard Deviation | pmol/L | | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
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| Primary | Serum Concentration of Thyroxin Binding Globulin (TBG) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. | All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6 | Posted | | Mean | Standard Deviation | mg/L | | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
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| Secondary | Serum Concentration of Androstenedione | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. | All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6 | Posted | | Mean | Standard Deviation | nmol/L | | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
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| Secondary | Serum Concentration of Dihydrotestosterone (DHT) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. | All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6 | Posted | | Mean | Standard Deviation | nmol/L | | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
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| Secondary | Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) | In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a maximum of 2 days. Each 13 cycles (28 days per cycle) constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant. | The "restricted ITT" set included all participants treated and excluded nonpregnant participants who didn't have >=1 cycle expected to be at risk for pregnancy (with recorded use of condoms or w/o sexual intercourse per diary card data). | Posted | | Number | 95% Confidence Interval | Pregnancies per 100 woman years | | 6 cycles | Woman years (rounded to nearest integer) | Woman years (rounded to nearest integer) | | ID | Title | Description |
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| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
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| Secondary | Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting | Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the "expected non-bleeding period" that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: NOMAC-E2: 21-day period starting on Day 4 of the cycle; LNG-EE: 21-day period starting on Day 1 of the cycle. | The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length. n=number of participants with evaluable cycles. | Posted | | Number | | Participants | | Every 28-day cycle for 6 cycles | | | | ID | Title | Description |
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| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
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| Secondary | Number of Participants With an Occurrence of Absence of Withdrawal Bleeding | Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Absence of withdrawal bleeding was defined as no bleeding/spotting episode that began during or continued into the "expected bleeding period". Expected bleeding period: NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle; LNG-EE: 7-day period starting on Day 22 of the cycle. | The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length. n=number of participants with evaluable cycles. | Posted | | Number | | Participants | | Every 28-day cycle for 6 cycles | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
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| Secondary | Number of Participants With an Occurrence of Breakthrough Bleeding | Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding was defined as any bleeding episode that occurred during the "expected non-bleeding period" that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: NOMAC-E2: 21-day period starting on Day 4 of the cycle; LNG-EE: 21-day period starting on Day 1 of the cycle. | The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length. n=number of participants with evaluable cycles. | Posted | | Number | | Participants | | Every 28-day cycle for 6 cycles | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
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| Secondary | Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only) | Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough spotting was defined as any spotting episode that occurred during the "expected non-bleeding period" that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: NOMAC-E2: 21-day period starting on Day 4 of the cycle; LNG-EE: 21-day period starting on Day 1 of the cycle. | The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length. n=number of participants with evaluable cycles. | Posted | | Number | | Participants | | Every 28-day cycle for 6 cycles | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
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| Secondary | Number of Participants With an Occurrence of Early Withdrawal Bleeding | Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Early withdrawal bleeding was defined as any withdrawal bleeding that started before the current "expected bleeding period". Expected bleeding period: NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle; LNG-EE: 7-day period starting on Day 22 of the cycle. | The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length. n=number of participants with evaluable cycles. | Posted | | Number | | Participants | | Every 28-day cycle for 6 cycles | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
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| Secondary | Number of Participants With an Occurrence of Continued Withdrawal Bleeding | Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Continued withdrawal bleeding was defined as any withdrawal bleeding that continued into the "expected non-bleeding period" of the next cycle. Expected non-bleeding period: NOMAC-E2: 21-day period starting on Day 4 of the cycle; LNG-EE: 21-day period starting on Day 1 of the cycle. | The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length. | Posted | | Number | | Participants | | Every 28-day cycle for 5 cycles | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. n= number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined). | | OG001 | LNG-EE | |
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| Secondary | Average Number of Breakthrough Bleeding/Spotting Days | Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the "expected non-bleeding period" that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: NOMAC-E2: 21-day period starting on Day 4 of the cycle; LNG-EE: 21-day period starting on Day 1 of the cycle. | ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length. n=number of participants who had breakthrough bleeding/spotting for the respective cycle. | Posted | | Mean | Standard Error | Days | | Every 28-day cycle for 6 cycles | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
|
| Secondary | Average Number of Withdrawal Bleeding/Spotting Days | Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Withdrawal bleeding/spotting was defined as any episode that occurred during the "expected bleeding period". Expected bleeding period: NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle; LNG-EE: 7-day period starting on Day 22 of the cycle. | ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length. n=number of participants who had withdrawal bleeding/spotting for the respective cycle. | Posted | | Mean | Standard Deviation | Days | | Every 28-day cycle for 6 cycles | | | | ID | Title | Description |
|---|
| OG000 | NOMAC-E2 | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles. | | OG001 | LNG-EE | Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles. |
|