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| ID | Type | Description | Link |
|---|---|---|---|
| Organon Protocol No. 292005 |
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The primary purpose of this study is to evaluate the effects of the NOMAC-E2 combined oral contraceptive (COC) on bone mineral density (BMD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NOMAC-E2 | Experimental | Nomegestrol Acetate (NOMAC) and Estradiol (E2), 2.5 mg NOMAC and 1.5 mg E2 monophasic COC |
|
| LNG-EE | Active Comparator | Levonorgestrel (LNG) and Ethinyl Estradiol (EE), 0.150 mg LNG and 0.030 mg EE monophasic COC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NOMAC-E2 | Drug | Nomegestrol Acetate and Estradiol Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 26 consecutive 28-day menstrual cycles (2 years). |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Z-scores of the Lumbar Spine (L2-L4) and Femoral Neck | BMD was measured by a Dual Energy X-ray Absorptiometry (DEXA) machine. The Z-score measures the distance of the measured BMD value from the appropriate normal age matched population mean value in units of standard deviation of this population. More negative scores indicate less BMD compared to age matched population, & more positive scores indicate higher BMD compared to age matched population. The adjusted mean change from baseline to the after Cycle 26 visit of the Z-scores is estimated using a baseline-adjusted analysis of covariance (ANCOVA). | Baseline and after cycle 26 (2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) | Contraceptive efficacy parameter of this trial was the 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 two days. Each 13 cycles (28 days per cycle) of exposure 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. |
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Inclusion criteria:
during treatment;
Exclusion criteria:
Family history of osteoporotic fracture below the age of 70;
Postgastrectomy;
History of eating disorder, viz. anorexia nervosa, bulimia;
Endocrine disorder (including controlled diabetes, [para]thyroid disease, Cushing's disease);
Rheumatoid arthritis;
Significant scoliosis;
Fasting parathyroid hormone (PTH) outside the reference range at screening;
Fasting calcitonin outside the reference range at screening;
Prolactin above the reference range (hyperprolactinemia) at screening;
Fasting cholesterol and/or triglycerides above the reference range for age at screening (treatment with lipid lowering drugs not allowed);
Engaging in vigorous exercise such as marathon, competitive swimming, triathlon;
Smoking more than ten cigarettes/day;
Use of more than two units of alcohol a day;
Use of one or more of the following drugs:
calcitonin;
ever treatment after childhood with fluorides;
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22762147 | Result | Sordal T, Grob P, Verhoeven C. Effects on bone mineral density of a monophasic combined oral contraceptive containing nomegestrol acetate/17beta-estradiol in comparison to levonorgestrel/ethinylestradiol. Acta Obstet Gynecol Scand. 2012 Nov;91(11):1279-85. doi: 10.1111/j.1600-0412.2012.01498.x. Epub 2012 Aug 21. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 26 consecutive 28-day cycles (2 years). |
| FG001 | 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 26 consecutive 28-day cycles (2 years). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 26 consecutive 28-day cycles (2 years). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) | Contraceptive efficacy parameter of this trial was the 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 two days. Each 13 cycles (28 days per cycle) of exposure 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. | Restricted Intent-To-Treat (ITT) analysis set included all participants treated, and further excluded non-pregnant participants without at least one cycle expected to be at risk for pregnancy(with recorded use of condoms or without confirmed sexual intercourse, as determined from the electronic diary data). | Posted | Number | 95% Confidence Interval | Pregnancies per 100 woman years | 2 years (26 cycles) | Woman years (rounded to nearest integer) | Woman years (rounded to nearest integer) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 26 consecutive 28-day cycles (2 years). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA (12.0) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA (12.0) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
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|
| LNG-EE | Drug | Levonorgestrel and Ethinyl Estradiol Tablets, 0.150 mg Levonorgestrel and 0.030 mg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 for 26 consecutive 28-day menstrual cycles (2 years). |
|
|
| 2 years (26 cycles) |
| 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 cards. 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: LNG-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle. | Every 28-day cycle for 26 cycles (2 years total) |
| 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 cards. 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: LNG-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2 group: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle. | Every 28-day cycle for 26 cycles (2 years total) |
| 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 cards. 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: LNG-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle. | Every 28-day cycle for 26 cycles (2 years total) |
| 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 cards. 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: LNG-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle. | Every 28-day cycle for 26 cycles (2 years total) |
| 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 cards. 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: LNG-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2 group: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle. | Every 28-day cycle for 26 cycles (2 years total) |
| 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 cards. 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: LNG-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle. | Every 28-day cycle for 26 cycles (2 years total) including one week after stopping treatment |
| 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 cards. Participants documented whether vaginal bleeding was present, and if so, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any bleeding/spotting episode that occurred during the "expected non-bleeding period" that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: LNG-EE: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle. | Every 28-day cycle for 26 cycles (2 years total) |
| 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 cards. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Withdrawal bleeding was defined as bleeding/spotting episode that started during or continued into the "expected bleeding period". Expected bleeding period: LNG-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2 group: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle. | Every 28-day cycle for 26 cycles (2 years total) |
| Pregnancy |
|
| Pregnancy wish |
|
| Lost to Follow-up |
|
| Other Reason |
|
| 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 26 consecutive 28-day cycles (2 years). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Baseline Z-scores of the Lumbar Spine (L2-L4) and Femoral Neck | The Z-score measures the distance of the measured Bone Mineral Density (BMD) value from the appropriate normal age matched population mean value in units of standard deviation of this population. The following formula was used: Z-score= BMD value minus mean (age-matched reference population)/ SD (age-matched reference population). More negative scores indicate less BMD compared to age matched population, and more positive scores indicate higher BMD compared to age matched population. | Mean | Full Range | score on a scale |
|
| 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 26 consecutive 28-day cycles (2 years). |
| 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 26 consecutive 28-day cycles (2 years). |
|
|
| 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 cards. 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: LNG-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 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 26 cycles (2 years total) |
|
|
|
| Primary | Mean Change From Baseline in Z-scores of the Lumbar Spine (L2-L4) and Femoral Neck | BMD was measured by a Dual Energy X-ray Absorptiometry (DEXA) machine. The Z-score measures the distance of the measured BMD value from the appropriate normal age matched population mean value in units of standard deviation of this population. More negative scores indicate less BMD compared to age matched population, & more positive scores indicate higher BMD compared to age matched population. The adjusted mean change from baseline to the after Cycle 26 visit of the Z-scores is estimated using a baseline-adjusted analysis of covariance (ANCOVA). | All-Subjects-Treated (AST) group consisted of all randomized participants who took at least one dose of trial medication. The number of participants in the AST group with a baseline value and a Week 26 value is presented. | Posted | Mean | Standard Deviation | score on a scale | Baseline and after cycle 26 (2 years) |
|
|
|
|
| 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 cards. 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: LNG-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2 group: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next 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 26 cycles (2 years total) |
|
|
|
| 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 cards. 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: LNG-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 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 26 cycles (2 years total) |
|
|
|
| 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 cards. 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: LNG-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 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 26 cycles (2 years total) |
|
|
|
| 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 cards. 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: LNG-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2 group: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next 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 26 cycles (2 years total) |
|
|
|
| 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 cards. 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: LNG-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 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 26 cycles (2 years total) including one week after stopping treatment |
|
|
|
| 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 cards. Participants documented whether vaginal bleeding was present, and if so, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any bleeding/spotting episode that occurred during the "expected non-bleeding period" that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: LNG-EE: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 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 Deviation | days | Every 28-day cycle for 26 cycles (2 years total) |
|
|
|
| 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 cards. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Withdrawal bleeding was defined as bleeding/spotting episode that started during or continued into the "expected bleeding period". Expected bleeding period: LNG-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2 group: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next 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 Deviation | days | Every 28-day cycle for 26 cycles (2 years total) |
|
|
|
| 1 |
| 56 |
| 42 |
| 56 |
| EG001 | 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 26 consecutive 28-day cycles (2 years). | 1 | 54 | 43 | 54 |
| Appendicitis | Infections and infestations | MedDRA (12.0) |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (12.0) |
|
| Nausea | Gastrointestinal disorders | MedDRA (12.0) |
|
| Bronchitis | Infections and infestations | MedDRA (12.0) |
|
| Chlamydial cervicitis | Infections and infestations | MedDRA (12.0) |
|
| Gastroenteritis | Infections and infestations | MedDRA (12.0) |
|
| Influenza | Infections and infestations | MedDRA (12.0) |
|
| Nasopharyngitis | Infections and infestations | MedDRA (12.0) |
|
| Sinusitis | Infections and infestations | MedDRA (12.0) |
|
| Vaginitis bacterial | Infections and infestations | MedDRA (12.0) |
|
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (12.0) |
|
| Weight increased | Investigations | MedDRA (12.0) |
|
| Headache | Nervous system disorders | MedDRA (12.0) |
|
| Libido decreased | Psychiatric disorders | MedDRA (12.0) |
|
| Mood altered | Psychiatric disorders | MedDRA (12.0) |
|
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA (12.0) |
|
| Dyspareunia | Reproductive system and breast disorders | MedDRA (12.0) |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA (12.0) |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (12.0) |
|
| Hot flush | Vascular disorders | MedDRA (12.0) |
|
The SPONSOR recognizes the right of the investigator(s) to publish, but all publications must be based on data validated and released by the SPONSOR. Any such scientific paper, presentation, or other communication concerning the clinical trial will first be submitted to the SPONSOR, at least six weeks ahead of estimated publication or presentation, for written consent, which shall not be withheld unreasonably.
| Cycle 3 (n=55 Nomac-E2/ n=48 LNG-EE) |
|
| Cycle 4 (n=53 Nomac-E2/ n=44 LNG-EE) |
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| Cycle 5 (n=50 Nomac-E2/ n=44 LNG-EE) |
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| Cycle 6 (n=51 Nomac-E2/ n=44 LNG-EE) |
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| Cycle 7 (n=48 Nomac-E2/ n=42 LNG-EE) |
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| Cycle 8 (n=47 Nomac-E2/ n=41 LNG-EE) |
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| Cycle 9 (n=47 Nomac-E2/ n=40 LNG-EE) |
|
| Cycle 10 (n=45 Nomac-E2/ n=40 LNG-EE) |
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| Cycle 11 (n=44 Nomac-E2/ n=40 LNG-EE) |
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| Cycle 12 (n=42 Nomac-E2/ n=40 LNG-EE) |
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| Cycle 13 (n=41 Nomac-E2/ n=39 LNG-EE) |
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| Cycle 14 (n=42 Nomac-E2/ n=39 LNG-EE) |
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| Cycle 15 (n=43 Nomac-E2/ n=38 LNG-EE) |
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| Cycle 16 (n=43 Nomac-E2/ n=38 LNG-EE) |
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| Cycle 17 (n=43 Nomac-E2/ n=37 LNG-EE) |
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| Cycle 18 (n=43 Nomac-E2/ n=37 LNG-EE) |
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| Cycle 19 (n=43 Nomac-E2/ n=37 LNG-EE) |
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| Cycle 20 (n=42 Nomac-E2/ n=36 LNG-EE) |
|
| Cycle 21 (n=41 Nomac-E2/ n=35 LNG-EE) |
|
| Cycle 22 (n=42 Nomac-E2/ n=34 LNG-EE) |
|
| Cycle 23 (n=43 Nomac-E2/ n=35 LNG-EE) |
|
| Cycle 24 (n=43 Nomac-E2/ n=35 LNG-EE) |
|
| Cycle 25 (n=42 Nomac-E2/ n=33 LNG-EE) |
|
| Cycle 26 (n=32 Nomac-E2/ n=21 LNG-EE) |
|
| ANCOVA | The ANCOVA included the Z-score values at baseline as adjusted factor. | 0.57 | No corrections for multiple comparisons were made for these safety parameters. The a-priori threshold for statistical significance was 0.05. | Difference of adjusted means | -0.030 | 2-Sided | 95 | -0.136 | 0.075 | NOMAC-E2 minus LNG-EE for femoral neck | Superiority or Other (legacy) |
| Cycle 3 (n=55 Nomac-E2/ n=48 LNG-EE) |
|
| Cycle 4 (n=53 Nomac-E2/ n=44 LNG-EE) |
|
| Cycle 5 (n=50 Nomac-E2/ n=44 LNG-EE) |
|
| Cycle 6 (n=51 Nomac-E2/ n=44 LNG-EE) |
|
| Cycle 7 (n=48 Nomac-E2/ n=42 LNG-EE) |
|
| Cycle 8 (n=47 Nomac-E2/ n=41 LNG-EE) |
|
| Cycle 9 (n=47 Nomac-E2/ n=40 LNG-EE) |
|
| Cycle 10 (n=45 Nomac-E2/ n=40 LNG-EE) |
|
| Cycle 11 (n=44 Nomac-E2/ n=40 LNG-EE) |
|
| Cycle 12 (n=42 Nomac-E2/ n=40 LNG-EE) |
|
| Cycle 13 (n=41 Nomac-E2/ n=39 LNG-EE) |
|
| Cycle 14 (n=42 Nomac-E2/ n=39 LNG-EE) |
|
| Cycle 15 (n=43 Nomac-E2/ n=38 LNG-EE) |
|
| Cycle 16 (n=43 Nomac-E2/ n=38 LNG-EE) |
|
| Cycle 17 (n=43 Nomac-E2/ n=37 LNG-EE) |
|
| Cycle 18 (n=43 Nomac-E2/ n=37 LNG-EE) |
|
| Cycle 19 (n=43 Nomac-E2/ n=37 LNG-EE) |
|
| Cycle 20 (n=42 Nomac-E2/ n=36 LNG-EE) |
|
| Cycle 21 (n=41 Nomac-E2/ n=35 LNG-EE) |
|
| Cycle 22 (n=42 Nomac-E2/ n=34 LNG-EE) |
|
| Cycle 23 (n=43 Nomac-E2/ n=35 LNG-EE) |
|
| Cycle 24 (n=43 Nomac-E2/ n=35 LNG-EE) |
|
| Cycle 25 (n=42 Nomac-E2/ n=33 LNG-EE) |
|
| Cycle 26 (n=32 Nomac-E2/ n=21 LNG-EE) |
|
| Cycle 3 (n=55 Nomac-E2/ n=48 LNG-EE) |
|
| Cycle 4 (n=53 Nomac-E2/ n=44 LNG-EE) |
|
| Cycle 5 (n=50 Nomac-E2/ n=44 LNG-EE) |
|
| Cycle 6 (n=51 Nomac-E2/ n=44 LNG-EE) |
|
| Cycle 7 (n=48 Nomac-E2/ n=42 LNG-EE) |
|
| Cycle 8 (n=47 Nomac-E2/ n=41 LNG-EE) |
|
| Cycle 9 (n=47 Nomac-E2/ n=40 LNG-EE) |
|
| Cycle 10 (n=45 Nomac-E2/ n=40 LNG-EE) |
|
| Cycle 11 (n=44 Nomac-E2/ n=40 LNG-EE) |
|
| Cycle 12 (n=42 Nomac-E2/ n=40 LNG-EE) |
|
| Cycle 13 (n=41 Nomac-E2/ n=39 LNG-EE) |
|
| Cycle 14 (n=42 Nomac-E2/ n=39 LNG-EE) |
|
| Cycle 15 (n=43 Nomac-E2/ n=38 LNG-EE) |
|
| Cycle 16 (n=43 Nomac-E2/ n=38 LNG-EE) |
|
| Cycle 17 (n=43 Nomac-E2/ n=37 LNG-EE) |
|
| Cycle 18 (n=43 Nomac-E2/ n=37 LNG-EE) |
|
| Cycle 19 (n=43 Nomac-E2/ n=37 LNG-EE) |
|
| Cycle 20 (n=42 Nomac-E2/ n=36 LNG-EE) |
|
| Cycle 21 (n=41 Nomac-E2/ n=35 LNG-EE) |
|
| Cycle 22 (n=42 Nomac-E2/ n=34 LNG-EE) |
|
| Cycle 23 (n=43 Nomac-E2/ n=35 LNG-EE) |
|
| Cycle 24 (n=43 Nomac-E2/ n=35 LNG-EE) |
|
| Cycle 25 (n=42 Nomac-E2/ n=33 LNG-EE) |
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| Cycle 26 (n=32 Nomac-E2/ n=21 LNG-EE) |
|
| Cycle 3 (n=55 Nomac-E2/ n=48 LNG-EE) |
|
| Cycle 4 (n=53 Nomac-E2/ n=44 LNG-EE) |
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| Cycle 5 (n=50 Nomac-E2/ n=44 LNG-EE) |
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| Cycle 6 (n=51 Nomac-E2/ n=44 LNG-EE) |
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| Cycle 7 (n=48 Nomac-E2/ n=42 LNG-EE) |
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| Cycle 8 (n=47 Nomac-E2/ n=41 LNG-EE) |
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| Cycle 9 (n=47 Nomac-E2/ n=40 LNG-EE) |
|
| Cycle 10 (n=45 Nomac-E2/ n=40 LNG-EE) |
|
| Cycle 11 (n=44 Nomac-E2/ n=40 LNG-EE) |
|
| Cycle 12 (n=42 Nomac-E2/ n=40 LNG-EE) |
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| Cycle 13 (n=41 Nomac-E2/ n=39 LNG-EE) |
|
| Cycle 14 (n=42 Nomac-E2/ n=39 LNG-EE) |
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| Cycle 15 (n=43 Nomac-E2/ n=38 LNG-EE) |
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| Cycle 16 (n=43 Nomac-E2/ n=38 LNG-EE) |
|
| Cycle 17 (n=43 Nomac-E2/ n=37 LNG-EE) |
|
| Cycle 18 (n=43 Nomac-E2/ n=37 LNG-EE) |
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| Cycle 19 (n=43 Nomac-E2/ n=37 LNG-EE) |
|
| Cycle 20 (n=42 Nomac-E2/ n=36 LNG-EE) |
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| Cycle 21 (n=41 Nomac-E2/ n=35 LNG-EE) |
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| Cycle 22 (n=42 Nomac-E2/ n=34 LNG-EE) |
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| Cycle 23 (n=43 Nomac-E2/ n=35 LNG-EE) |
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| Cycle 24 (n=43 Nomac-E2/ n=35 LNG-EE) |
|
| Cycle 25 (n=42 Nomac-E2/ n=33 LNG-EE) |
|
| Cycle 26 (n=32 Nomac-E2/ n=21 LNG-EE) |
|
| Cycle 3 (n=55 Nomac-E2/ n=48 LNG-EE) |
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| Cycle 4 (n=53 Nomac-E2/ n=44 LNG-EE) |
|
| Cycle 5 (n=50 Nomac-E2/ n=44 LNG-EE) |
|
| Cycle 6 (n=51 Nomac-E2/ n=44 LNG-EE) |
|
| Cycle 7 (n=48 Nomac-E2/ n=42 LNG-EE) |
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| Cycle 8 (n=47 Nomac-E2/ n=41 LNG-EE) |
|
| Cycle 9 (n=47 Nomac-E2/ n=40 LNG-EE) |
|
| Cycle 10 (n=45 Nomac-E2/ n=40 LNG-EE) |
|
| Cycle 11 (n=44 Nomac-E2/ n=40 LNG-EE) |
|
| Cycle 12 (n=42 Nomac-E2/ n=40 LNG-EE) |
|
| Cycle 13 (n=41 Nomac-E2/ n=39 LNG-EE) |
|
| Cycle 14 (n=42 Nomac-E2/ n=39 LNG-EE) |
|
| Cycle 15 (n=43 Nomac-E2/ n=38 LNG-EE) |
|
| Cycle 16 (n=43 Nomac-E2/ n=38 LNG-EE) |
|
| Cycle 17 (n=43 Nomac-E2/ n=37 LNG-EE) |
|
| Cycle 18 (n=43 Nomac-E2/ n=37 LNG-EE) |
|
| Cycle 19 (n=43 Nomac-E2/ n=37 LNG-EE) |
|
| Cycle 20 (n=42 Nomac-E2/ n=36 LNG-EE) |
|
| Cycle 21 (n=41 Nomac-E2/ n=35 LNG-EE) |
|
| Cycle 22 (n=42 Nomac-E2/ n=34 LNG-EE) |
|
| Cycle 23 (n=43 Nomac-E2/ n=35 LNG-EE) |
|
| Cycle 24 (n=43 Nomac-E2/ n=35 LNG-EE) |
|
| Cycle 25 (n=42 Nomac-E2/ n=33 LNG-EE) |
|
| Cycle 26 (n=32 Nomac-E2/ n=21 LNG-EE) |
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| Cycle 3 (n=53 Nomac-E2/ n=45 LNG-EE) |
|
| Cycle 4 (n=51 Nomac-E2/ n=43 LNG-EE) |
|
| Cycle 5 (n=50 Nomac-E2/ n=44 LNG-EE) |
|
| Cycle 6 (n=50 Nomac-E2/ n=43 LNG-EE) |
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| Cycle 7 (n=48 Nomac-E2/ n=41 LNG-EE) |
|
| Cycle 8 (n=47 Nomac-E2/ n=41 LNG-EE) |
|
| Cycle 9 (n=47 Nomac-E2/ n=40 LNG-EE) |
|
| Cycle 10 (n=44 Nomac-E2/ n=39 LNG-EE) |
|
| Cycle 11 (n=43 Nomac-E2/ n=40 LNG-EE) |
|
| Cycle 12 (n=42 Nomac-E2/ n=40 LNG-EE) |
|
| Cycle 13 (n=41 Nomac-E2/ n=38 LNG-EE) |
|
| Cycle 14 (n=42 Nomac-E2/ n=38 LNG-EE) |
|
| Cycle 15 (n=43 Nomac-E2/ n=38 LNG-EE) |
|
| Cycle 16 (n=43 Nomac-E2/ n=38 LNG-EE) |
|
| Cycle 17 (n=43 Nomac-E2/ n=37 LNG-EE) |
|
| Cycle 18 (n=43 Nomac-E2/ n=37 LNG-EE) |
|
| Cycle 19 (n=43 Nomac-E2/ n=36 LNG-EE) |
|
| Cycle 20 (n=42 Nomac-E2/ n=36 LNG-EE) |
|
| Cycle 21 (n=41 Nomac-E2/ n=34 LNG-EE) |
|
| Cycle 22 (n=42 Nomac-E2/ n=34 LNG-EE) |
|
| Cycle 23 (n=43 Nomac-E2/ n=35 LNG-EE) |
|
| Cycle 24 (n=43 Nomac-E2/ n=35 LNG-EE) |
|
| Cycle 25 (n=42 Nomac-E2/ n=33 LNG-EE) |
|
| Cycle 26 (n=4Nomac-E2/ n=1 LNG-EE) |
|
| Cycle 3 (n=15 Nomac-E2/ n=3 LNG-EE) |
|
| Cycle 4 (n=12 Nomac-E2/ n=2 LNG-EE) |
|
| Cycle 5 (n=11 Nomac-E2/ n=2 LNG-EE) |
|
| Cycle 6 (n=10 Nomac-E2/ n=5 LNG-EE) |
|
| Cycle 7 (n=6 Nomac-E2/ n=5 LNG-EE) |
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| Cycle 8 (n=4 Nomac-E2/ n=3 LNG-EE) |
|
| Cycle 9 (n=9 Nomac-E2/ n=8 LNG-EE) |
|
| Cycle 10 (n=7 Nomac-E2/ n=1 LNG-EE) |
|
| Cycle 11 (n=6 Nomac-E2/ n=3 LNG-EE) |
|
| Cycle 12 (n=5 Nomac-E2/ n=4 LNG-EE) |
|
| Cycle 13 (n=6 Nomac-E2/ n=4 LNG-EE) |
|
| Cycle 14 (n=3 Nomac-E2/ n=3 LNG-EE) |
|
| Cycle 15 (n=2 Nomac-E2/ n=2 LNG-EE) |
|
| Cycle 16 (n=6 Nomac-E2/ n=2 LNG-EE) |
|
| Cycle 17 (n=4 Nomac-E2/ n=2 LNG-EE) |
|
| Cycle 18 (n=1 Nomac-E2/ n=3 LNG-EE) |
|
| Cycle 19 (n=2 Nomac-E2/ n=2 LNG-EE) |
|
| Cycle 20 (n=4 Nomac-E2/ n=2 LNG-EE) |
|
| Cycle 21 (n=4 Nomac-E2/ n=1 LNG-EE) |
|
| Cycle 22 (n=2 Nomac-E2/ n=1 LNG-EE) |
|
| Cycle 23 (n=4 Nomac-E2/ n=5 LNG-EE) |
|
| Cycle 24 (n=2 Nomac-E2/ n=3 LNG-EE) |
|
| Cycle 25 (n=6 Nomac-E2/ n=2 LNG-EE) |
|
| Cycle 26 (n=3 Nomac-E2/ n=0 LNG-EE) |
|
| Cycle 3 (n=46 Nomac-E2/ n=47 LNG-EE) |
|
| Cycle 4 (n=37 Nomac-E2/ n=44 LNG-EE) |
|
| Cycle 5 (n=40 Nomac-E2/ n=44 LNG-EE) |
|
| Cycle 6 (n=37 Nomac-E2/ n=44 LNG-EE) |
|
| Cycle 7 (n=33 Nomac-E2/ n=41 LNG-EE) |
|
| Cycle 8 (n=35 Nomac-E2/ n=41 LNG-EE) |
|
| Cycle 9 (n=34 Nomac-E2/ n=37 LNG-EE) |
|
| Cycle 10 (n=31 Nomac-E2/ n=39 LNG-EE) |
|
| Cycle 11 (n=28 Nomac-E2/ n=40 LNG-EE) |
|
| Cycle 12 (n=30 Nomac-E2/ n=40 LNG-EE) |
|
| Cycle 13 (n=30 Nomac-E2/ n=39 LNG-EE) |
|
| Cycle 14 (n=30 Nomac-E2/ n=37 LNG-EE) |
|
| Cycle 15 (n=22 Nomac-E2/ n=36 LNG-EE) |
|
| Cycle 16 (n=26 Nomac-E2/ n=37 LNG-EE) |
|
| Cycle 17 (n=25 Nomac-E2/ n=36 LNG-EE) |
|
| Cycle 18 (n=30 Nomac-E2/ n=34 LNG-EE) |
|
| Cycle 19 (n=25 Nomac-E2/ n=35 LNG-EE) |
|
| Cycle 20 (n=22 Nomac-E2/ n=34 LNG-EE) |
|
| Cycle 21 (n=24 Nomac-E2/ n=33 LNG-EE) |
|
| Cycle 22 (n=26 Nomac-E2/ n=32 LNG-EE) |
|
| Cycle 23 (n=26 Nomac-E2/ n=31 LNG-EE) |
|
| Cycle 24 (n=24 Nomac-E2/ n=32 LNG-EE) |
|
| Cycle 25 (n=27 Nomac-E2/ n=31 LNG-EE) |
|
| Cycle 26 (n=8 Nomac-E2/ n=10 LNG-EE) |
|