Contraception
Conditions
Brief summary
The primary purpose of this study is to evaluate the effects of the nomegestrol acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) on ovarian function.
Interventions
DRUGNOMAC-E2
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 6 consecutive 28-day menstrual cycles.
DRUGDRSP-EE
Drospirenone and Ethinyl Estradiol Tablets, 3 mg DRSP and 30 mcg EE taken once daily from Day 1 of menstrual period up to and including Day 28 for 6 consecutive 28-day menstrual cycles.
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Willing to use COC for at least 6 cycles. * 18 - 35 years of age at screening. * Body Mass Index (BMI) of \>/= 17 and \</= 35. * Good physical and mental health. * Willing to use condoms as the sole contraceptive method during screening cycle and 1 post-treatment cycle. * Willing to give informed consent.
Exclusion criteria
* Contraindications for contraceptive steroids (general). * Additional contraindications (renal, hepatic or adrenal insufficiency). * Breastfeeding. * Present use (or use within 2 months prior to start of the trial medication) of the following drugs: phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole, sex steroids (other than pre- and post treatment contraceptive method) and herbal remedies containing Hypericum perforatum (St. John's Wort). * Administration of any other investigational drugs and/or participation in another clinical trial within 2 months prior to the start of the trial medication or during the trial period. * Abnormal cervical smear at screening, or documentation of an abnormal smear performed within 6 months before screening. * Clinically relevant abnormal laboratory result at screening as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect on Ovarian Function as Determined by the Number of Participants With an Occurrence of Ovulation | Cycle 1, Cycle 2, and Cycle 6 | During treatment, ovulation was assessed for each participant by the investigator on the basis of ultrasound scanning (USS). The final analysis was based on assessor-blind adjudication. |
| Effect on Ovarian Function as Determined by the Maximum Follicle Diameter | Screening cycle, Cycle 1, Cycle 2, Cycle 3, and Cycle 6 | The maximum follicular diameter was defined as the largest follicular diameter during a treatment cycle. |
| Effect on Ovarian Function as Determined by the Maximum Progesterone Value | Screening cycle, Cycle 1, Cycle 2, Cycle 3, and Cycle 6 | The maximum progesterone value was defined as the largest value during a cycle. |
| Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 1, Cycle 2, Cycle 3, and Cycle 6 | The parameter was measured at pre-defined study days. |
| Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 1, Cycle 2, Cycle 3, and Cycle 6 | The parameter was measured at pre-defined study days. |
| Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 1, Cycle 2, Cycle 3, and Cycle 6 | The parameter was measured at pre-defined study days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only) | Every 28-day cycle for 6 cycles | Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card 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: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2:21-day period starting on Day 4 of the cycle. |
| Number of Participants With an Occurrence of Early Withdrawal Bleeding | Every 28-day cycle for 6 cycles | Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card 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: DRSP-EE: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle. |
| Effect on Cervical Mucus as Determined by Insler Score | Screening Cycle, Cycle 1, Cycle 2, and Cycle 7 (post-treatment cycle) | The Insler Score was assessed on Day 6 after ovulation during the Screening Cycle, on Day 21 of Cycle 1, and when the maximum follicle diameter was greater than or equal to 15 mm. The Insler Score consisted of four categories each scaled from 0 (none) to 3 (complete). The higher the score, the greater the cervical reaction. |
| Average Number of Breakthrough Bleeding/Spotting Days | Every 28-day cycle for 6 cycles | Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card 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: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle. |
| Average Number of Withdrawal Bleeding Days | Every 28-day cycle for 6 cycles | Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. 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: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle. |
| Number of Participants With an Occurrence of Continued Withdrawal Bleeding | Every 28-day cycle for 5 cycles | Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card 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: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle. |
| Effect on Maximum Endometrial Thickness | Screening Cycle, Cycle 1, Cycle 2, and Cycle 6 | Maximum endometrial thickness was defined as the largest endometrial thickness during a cycle. |
| Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) | 6 cycles | 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 woman years) that the women were under risk of becoming pregnant. |
| Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting | Every 28-day cycle for 6 cycles | Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card 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: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle. |
| Number of Participants With an Occurrence of Absence of Withdrawal Bleeding | Every 28-day cycle for 6 cycles | Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card 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: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle. |
| Number of Participants With an Occurrence of Breakthrough Bleeding | Every 28-day cycle for 6 cycles | Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card 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: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2:21-day period starting on Day 4 of the cycle. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 menstrual cycles. | 32 |
| DRSP-EE Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol 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 menstrual cycles. | 16 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 0 |
| Overall Study | Other Reason | 1 | 1 |
Baseline characteristics
| Characteristic | NOMAC-E2 | DRSP-EE | Total |
|---|---|---|---|
| Age, Continuous | 22.8 years STANDARD_DEVIATION 3.3 | 22.9 years STANDARD_DEVIATION 4.3 | 22.8 years STANDARD_DEVIATION 3.6 |
| Sex: Female, Male Female | 32 Participants | 16 Participants | 48 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 30 / 32 | 15 / 16 |
| serious Total, serious adverse events | 1 / 32 | 0 / 16 |
Outcome results
Primary
Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2)
The parameter was measured at pre-defined study days.
Time frame: Cycle 1, Cycle 2, Cycle 3, and Cycle 6
Population: ITT group consisted of all participants who were treated.~n=number of participants with non-missing values at the respective time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 1, Day 5 (n=32 NOMAC-E2 / n=16 DRSP-EE) | 194.57 picomoles per liter (pmol/L) | Standard Deviation 93.17 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 2, Day 11 (n=29 NOMAC-E2 / n=16 DRSP-EE) | 185.77 picomoles per liter (pmol/L) | Standard Deviation 63.97 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 1, Day 21 (n=30 NOMAC-E2 / n=16 DRSP-EE) | 191.08 picomoles per liter (pmol/L) | Standard Deviation 139.5 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 2, Day 14 (n=29 NOMAC-E2 / n=15 DRSP-EE) | 183.66 picomoles per liter (pmol/L) | Standard Deviation 74.39 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 1, Day 11 (n=30 NOMAC-E2 / n=16 DRSP-EE) | 184.63 picomoles per liter (pmol/L) | Standard Deviation 95.7 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 2, Day 18 (n=28 NOMAC-E2 / n=15 DRSP-EE) | 213.84 picomoles per liter (pmol/L) | Standard Deviation 123.35 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 1, Day 24 (n=30 NOMAC-E2 / n=16 DRSP-EE) | 232.80 picomoles per liter (pmol/L) | Standard Deviation 281.15 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 2, Day 21 (n=27 NOMAC-E2 / n=16 DRSP-EE) | 192.47 picomoles per liter (pmol/L) | Standard Deviation 66.43 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 1, Day 2 (n=32 NOMAC-E2 / n=16 DRSP-EE) | 168.75 picomoles per liter (pmol/L) | Standard Deviation 62.37 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 2, Day 24 (n=27 NOMAC-E2 / n=16 DRSP-EE) | 206.20 picomoles per liter (pmol/L) | Standard Deviation 147.27 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 1, Day 27 (n=30 NOMAC-E2 / n=16 DRSP-EE) | 99.65 picomoles per liter (pmol/L) | Standard Deviation 42.53 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 2, Day 27 (n=27 NOMAC-E2 / n=16 DRSP-EE) | 97.99 picomoles per liter (pmol/L) | Standard Deviation 40.88 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 1, Day 14 (n=29 NOMAC-E2 / n=16 DRSP-EE) | 197.57 picomoles per liter (pmol/L) | Standard Deviation 123.23 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 3, Day 2 (n=27 NOMAC-E2 / n=14 DRSP-EE) | 148.16 picomoles per liter (pmol/L) | Standard Deviation 52.09 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 2, Day 2 (n=29 NOMAC-E2 / n=16 DRSP-EE) | 176.43 picomoles per liter (pmol/L) | Standard Deviation 91.99 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 6, Day 14 (n=25 NOMAC-E2 / n=14 DRSP-EE) | 205.89 picomoles per liter (pmol/L) | Standard Deviation 104.45 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 1, Day 8 (n=32 NOMAC-E2 / n=16 DRSP-EE) | 172.35 picomoles per liter (pmol/L) | Standard Deviation 66.92 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 6, Day 18 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 200.04 picomoles per liter (pmol/L) | Standard Deviation 90.28 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 2, Day 5 (n=29 NOMAC-E2 / n=15 DRSP-EE) | 213.64 picomoles per liter (pmol/L) | Standard Deviation 104.85 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 6, Day 21 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 188.47 picomoles per liter (pmol/L) | Standard Deviation 90.12 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 1, Day 18 (n=29 NOMAC-E2 / n=16 DRSP-EE) | 182.72 picomoles per liter (pmol/L) | Standard Deviation 84.03 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 6, Day 24 (n=26 NOMAC-E2 / n=14 DRSP-EE) | 187.16 picomoles per liter (pmol/L) | Standard Deviation 106.6 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 2, Day 8 (n=29 NOMAC-E2 / n=16 DRSP-EE) | 192.59 picomoles per liter (pmol/L) | Standard Deviation 68.83 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 6, Day 27 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 99.51 picomoles per liter (pmol/L) | Standard Deviation 35.6 |
| DRSP-EE | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 2, Day 18 (n=28 NOMAC-E2 / n=15 DRSP-EE) | 60.11 picomoles per liter (pmol/L) | Standard Deviation 0.95 |
| DRSP-EE | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 1, Day 2 (n=32 NOMAC-E2 / n=16 DRSP-EE) | 79.82 picomoles per liter (pmol/L) | Standard Deviation 18.34 |
| DRSP-EE | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 1, Day 5 (n=32 NOMAC-E2 / n=16 DRSP-EE) | 66.66 picomoles per liter (pmol/L) | Standard Deviation 10.53 |
| DRSP-EE | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 1, Day 8 (n=32 NOMAC-E2 / n=16 DRSP-EE) | 61.15 picomoles per liter (pmol/L) | Standard Deviation 3.66 |
| DRSP-EE | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 1, Day 11 (n=30 NOMAC-E2 / n=16 DRSP-EE) | 60.51 picomoles per liter (pmol/L) | Standard Deviation 1.96 |
| DRSP-EE | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 1, Day 14 (n=29 NOMAC-E2 / n=16 DRSP-EE) | 60.26 picomoles per liter (pmol/L) | Standard Deviation 1.48 |
| DRSP-EE | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 1, Day 18 (n=29 NOMAC-E2 / n=16 DRSP-EE) | 60.58 picomoles per liter (pmol/L) | Standard Deviation 2.93 |
| DRSP-EE | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 1, Day 21 (n=30 NOMAC-E2 / n=16 DRSP-EE) | 59.82 picomoles per liter (pmol/L) | Standard Deviation 0 |
| DRSP-EE | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 1, Day 24 (n=30 NOMAC-E2 / n=16 DRSP-EE) | 69.84 picomoles per liter (pmol/L) | Standard Deviation 23.5 |
| DRSP-EE | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 1, Day 27 (n=30 NOMAC-E2 / n=16 DRSP-EE) | 150.79 picomoles per liter (pmol/L) | Standard Deviation 46.45 |
| DRSP-EE | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 2, Day 2 (n=29 NOMAC-E2 / n=16 DRSP-EE) | 135.86 picomoles per liter (pmol/L) | Standard Deviation 106.62 |
| DRSP-EE | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 2, Day 5 (n=29 NOMAC-E2 / n=15 DRSP-EE) | 142.74 picomoles per liter (pmol/L) | Standard Deviation 186.99 |
| DRSP-EE | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 2, Day 8 (n=29 NOMAC-E2 / n=16 DRSP-EE) | 131.98 picomoles per liter (pmol/L) | Standard Deviation 196.51 |
| DRSP-EE | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 2, Day 11 (n=29 NOMAC-E2 / n=16 DRSP-EE) | 112.23 picomoles per liter (pmol/L) | Standard Deviation 152.19 |
| DRSP-EE | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 2, Day 14 (n=29 NOMAC-E2 / n=15 DRSP-EE) | 78.44 picomoles per liter (pmol/L) | Standard Deviation 69.99 |
| DRSP-EE | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 6, Day 27 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 133.49 picomoles per liter (pmol/L) | Standard Deviation 61.28 |
| DRSP-EE | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 2, Day 21 (n=27 NOMAC-E2 / n=16 DRSP-EE) | 59.91 picomoles per liter (pmol/L) | Standard Deviation 0.37 |
| DRSP-EE | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 2, Day 24 (n=27 NOMAC-E2 / n=16 DRSP-EE) | 61.33 picomoles per liter (pmol/L) | Standard Deviation 3.95 |
| DRSP-EE | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 2, Day 27 (n=27 NOMAC-E2 / n=16 DRSP-EE) | 155.63 picomoles per liter (pmol/L) | Standard Deviation 63.65 |
| DRSP-EE | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 3, Day 2 (n=27 NOMAC-E2 / n=14 DRSP-EE) | 141.11 picomoles per liter (pmol/L) | Standard Deviation 115.89 |
| DRSP-EE | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 6, Day 14 (n=25 NOMAC-E2 / n=14 DRSP-EE) | 59.98 picomoles per liter (pmol/L) | Standard Deviation 0.59 |
| DRSP-EE | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 6, Day 18 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 64.20 picomoles per liter (pmol/L) | Standard Deviation 12.99 |
| DRSP-EE | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 6, Day 21 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 60.82 picomoles per liter (pmol/L) | Standard Deviation 3.02 |
| DRSP-EE | Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2) | Cycle 6, Day 24 (n=26 NOMAC-E2 / n=14 DRSP-EE) | 69.60 picomoles per liter (pmol/L) | Standard Deviation 33.97 |
Primary
Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH)
The parameter was measured at pre-defined study days.
Time frame: Cycle 1, Cycle 2, Cycle 3, and Cycle 6
Population: ITT group consisted of all participants who were treated.~n=number of participants with non-missing values at the respective time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 1, Day 21 (n=30 NOMAC-E2 / n=16 DRSP-EE) | 2.87 International units per liter (IU/L) | Standard Deviation 1.96 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 1, Day 5 (n=32 NOMAC-E2 / n=16 DRSP-EE) | 4.08 International units per liter (IU/L) | Standard Deviation 1.59 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 1, Day 8 (n=32 NOMAC-E2 / n=16 DRSP-EE) | 3.59 International units per liter (IU/L) | Standard Deviation 1.59 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 1, Day 11 (n=30 NOMAC-E2 / n=16 DRSP-EE) | 3.44 International units per liter (IU/L) | Standard Deviation 2.07 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 1, Day 14 (n=29 NOMAC-E2 / n=16 DRSP-EE) | 3.06 International units per liter (IU/L) | Standard Deviation 1.9 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 1, Day 18 (n=29 NOMAC-E2 / n=16 DRSP-EE) | 2.95 International units per liter (IU/L) | Standard Deviation 1.76 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 1, Day 2 (n=32 NOMAC-E2 / n=16 DRSP-EE) | 4.29 International units per liter (IU/L) | Standard Deviation 1.45 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 1, Day 24 (n=30 NOMAC-E2 / n=16 DRSP-EE) | 2.88 International units per liter (IU/L) | Standard Deviation 1.99 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 1, Day 27 (n=30 NOMAC-E2 / n=16 DRSP-EE) | 5.42 International units per liter (IU/L) | Standard Deviation 2.51 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 2, Day 2 (n=29 NOMAC-E2 / n=16 DRSP-EE) | 5.32 International units per liter (IU/L) | Standard Deviation 2.05 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 2, Day 5 (n=29 NOMAC-E2 / n=15 DRSP-EE) | 4.59 International units per liter (IU/L) | Standard Deviation 1.54 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 2, Day 8 (n=29 NOMAC-E2 / n=16 DRSP-EE) | 3.99 International units per liter (IU/L) | Standard Deviation 1.71 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 2, Day 11 (n=29 NOMAC-E2 / n=16 DRSP-EE) | 3.47 International units per liter (IU/L) | Standard Deviation 1.68 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 2, Day 14 (n=29 NOMAC-E2 / n=15 DRSP-EE) | 3.34 International units per liter (IU/L) | Standard Deviation 2.18 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 2, Day 18 (n=28 NOMAC-E2 / n=15 DRSP-EE) | 3.18 International units per liter (IU/L) | Standard Deviation 1.84 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 2, Day 21 (n=27 NOMAC-E2 / n=16 DRSP-EE) | 3.02 International units per liter (IU/L) | Standard Deviation 1.64 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 2, Day 24 (n=27 NOMAC-E2 / n=16 DRSP-EE) | 3.05 International units per liter (IU/L) | Standard Deviation 1.76 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 2, Day 27 (n=27 NOMAC-E2 / n=16 DRSP-EE) | 5.92 International units per liter (IU/L) | Standard Deviation 2.77 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 3, Day 2 (n=27 NOMAC-E2 / n=14 DRSP-EE) | 6.01 International units per liter (IU/L) | Standard Deviation 2.08 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 6, Day 14 (n=25 NOMAC-E2 / n=14 DRSP-EE) | 3.08 International units per liter (IU/L) | Standard Deviation 1.88 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 6, Day 18 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 2.82 International units per liter (IU/L) | Standard Deviation 1.79 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 6, Day 21 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 3.30 International units per liter (IU/L) | Standard Deviation 2.14 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 6, Day 24 (n=26 NOMAC-E2 / n=14 DRSP-EE) | 2.86 International units per liter (IU/L) | Standard Deviation 2.09 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 6, Day 27 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 5.65 International units per liter (IU/L) | Standard Deviation 2.57 |
| DRSP-EE | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 6, Day 24 (n=26 NOMAC-E2 / n=14 DRSP-EE) | 3.18 International units per liter (IU/L) | Standard Deviation 3.04 |
| DRSP-EE | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 1, Day 2 (n=32 NOMAC-E2 / n=16 DRSP-EE) | 4.51 International units per liter (IU/L) | Standard Deviation 1.14 |
| DRSP-EE | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 2, Day 11 (n=29 NOMAC-E2 / n=16 DRSP-EE) | 1.96 International units per liter (IU/L) | Standard Deviation 1.13 |
| DRSP-EE | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 1, Day 5 (n=32 NOMAC-E2 / n=16 DRSP-EE) | 4.23 International units per liter (IU/L) | Standard Deviation 1.33 |
| DRSP-EE | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 3, Day 2 (n=27 NOMAC-E2 / n=14 DRSP-EE) | 5.17 International units per liter (IU/L) | Standard Deviation 1.44 |
| DRSP-EE | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 1, Day 8 (n=32 NOMAC-E2 / n=16 DRSP-EE) | 3.40 International units per liter (IU/L) | Standard Deviation 1.57 |
| DRSP-EE | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 2, Day 14 (n=29 NOMAC-E2 / n=15 DRSP-EE) | 1.44 International units per liter (IU/L) | Standard Deviation 1 |
| DRSP-EE | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 1, Day 11 (n=30 NOMAC-E2 / n=16 DRSP-EE) | 2.46 International units per liter (IU/L) | Standard Deviation 1.4 |
| DRSP-EE | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 6, Day 21 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 0.92 International units per liter (IU/L) | Standard Deviation 0.96 |
| DRSP-EE | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 1, Day 14 (n=29 NOMAC-E2 / n=16 DRSP-EE) | 2.32 International units per liter (IU/L) | Standard Deviation 1.71 |
| DRSP-EE | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 2, Day 18 (n=28 NOMAC-E2 / n=15 DRSP-EE) | 1.22 International units per liter (IU/L) | Standard Deviation 0.94 |
| DRSP-EE | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 1, Day 18 (n=29 NOMAC-E2 / n=16 DRSP-EE) | 1.91 International units per liter (IU/L) | Standard Deviation 1.69 |
| DRSP-EE | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 6, Day 14 (n=25 NOMAC-E2 / n=14 DRSP-EE) | 1.43 International units per liter (IU/L) | Standard Deviation 1.32 |
| DRSP-EE | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 1, Day 21 (n=30 NOMAC-E2 / n=16 DRSP-EE) | 1.61 International units per liter (IU/L) | Standard Deviation 1.53 |
| DRSP-EE | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 2, Day 21 (n=27 NOMAC-E2 / n=16 DRSP-EE) | 1.04 International units per liter (IU/L) | Standard Deviation 0.98 |
| DRSP-EE | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 1, Day 24 (n=30 NOMAC-E2 / n=16 DRSP-EE) | 4.50 International units per liter (IU/L) | Standard Deviation 4.05 |
| DRSP-EE | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 6, Day 27 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 6.22 International units per liter (IU/L) | Standard Deviation 2.99 |
| DRSP-EE | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 1, Day 27 (n=30 NOMAC-E2 / n=16 DRSP-EE) | 7.91 International units per liter (IU/L) | Standard Deviation 3.95 |
| DRSP-EE | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 2, Day 24 (n=27 NOMAC-E2 / n=16 DRSP-EE) | 3.52 International units per liter (IU/L) | Standard Deviation 3.51 |
| DRSP-EE | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 2, Day 2 (n=29 NOMAC-E2 / n=16 DRSP-EE) | 5.48 International units per liter (IU/L) | Standard Deviation 1.82 |
| DRSP-EE | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 6, Day 18 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 1.29 International units per liter (IU/L) | Standard Deviation 1.28 |
| DRSP-EE | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 2, Day 5 (n=29 NOMAC-E2 / n=15 DRSP-EE) | 4.08 International units per liter (IU/L) | Standard Deviation 1.54 |
| DRSP-EE | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 2, Day 27 (n=27 NOMAC-E2 / n=16 DRSP-EE) | 6.99 International units per liter (IU/L) | Standard Deviation 2.78 |
| DRSP-EE | Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH) | Cycle 2, Day 8 (n=29 NOMAC-E2 / n=16 DRSP-EE) | 2.77 International units per liter (IU/L) | Standard Deviation 1.19 |
Primary
Effect on Ovarian Function as Determined by Luteinizing Hormone (LH)
The parameter was measured at pre-defined study days.
Time frame: Cycle 1, Cycle 2, Cycle 3, and Cycle 6
Population: ITT group consisted of all participants who were treated.~n=number of participants with non-missing values at the respective time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 6, Day 18 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 1.88 IU/L | Standard Deviation 2.05 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 1, Day 5 (n=32 NOMAC-E2 / n=16 DRSP-EE) | 2.98 IU/L | Standard Deviation 1.49 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 2, Day 24 (n=27 NOMAC-E2 / n=16 DRSP-EE) | 1.81 IU/L | Standard Deviation 1.75 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 2, Day 27 (n=27 NOMAC-E2 / n=16 DRSP-EE) | 3.37 IU/L | Standard Deviation 2.9 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 3, Day 2 (n=27 NOMAC-E2 / n=14 DRSP-EE) | 3.71 IU/L | Standard Deviation 2.23 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 6, Day 14 (n=25 NOMAC-E2 / n=14 DRSP-EE) | 2.29 IU/L | Standard Deviation 1.86 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 1, Day 2 (n=32 NOMAC-E2 / n=16 DRSP-EE) | 3.73 IU/L | Standard Deviation 1.64 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 6, Day 21 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 2.00 IU/L | Standard Deviation 1.68 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 6, Day 24 (n=26 NOMAC-E2 / n=14 DRSP-EE) | 1.85 IU/L | Standard Deviation 1.75 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 6, Day 27 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 3.13 IU/L | Standard Deviation 2.21 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 1, Day 8 (n=32 NOMAC-E2 / n=16 DRSP-EE) | 2.50 IU/L | Standard Deviation 1.68 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 1, Day 11 (n=30 NOMAC-E2 / n=16 DRSP-EE) | 2.13 IU/L | Standard Deviation 1.5 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 1, Day 14 (n=29 NOMAC-E2 / n=16 DRSP-EE) | 1.85 IU/L | Standard Deviation 1.77 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 1, Day 18 (n=29 NOMAC-E2 / n=16 DRSP-EE) | 1.76 IU/L | Standard Deviation 1.41 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 1, Day 21 (n=30 NOMAC-E2 / n=16 DRSP-EE) | 1.45 IU/L | Standard Deviation 1.33 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 1, Day 24 (n=30 NOMAC-E2 / n=16 DRSP-EE) | 1.59 IU/L | Standard Deviation 1.44 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 1, Day 27 (n=30 NOMAC-E2 / n=16 DRSP-EE) | 3.04 IU/L | Standard Deviation 1.95 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 2, Day 2 (n=29 NOMAC-E2 / n=16 DRSP-EE) | 3.47 IU/L | Standard Deviation 2.2 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 2, Day 5 (n=29 NOMAC-E2 / n=15 DRSP-EE) | 3.04 IU/L | Standard Deviation 1.94 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 2, Day 8 (n=29 NOMAC-E2 / n=16 DRSP-EE) | 2.48 IU/L | Standard Deviation 1.85 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 2, Day 11 (n=29 NOMAC-E2 / n=16 DRSP-EE) | 2.54 IU/L | Standard Deviation 2.01 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 2, Day 14 (n=29 NOMAC-E2 / n=15 DRSP-EE) | 2.39 IU/L | Standard Deviation 2.17 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 2, Day 18 (n=28 NOMAC-E2 / n=15 DRSP-EE) | 2.05 IU/L | Standard Deviation 1.76 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 2, Day 21 (n=27 NOMAC-E2 / n=16 DRSP-EE) | 1.68 IU/L | Standard Deviation 1.44 |
| DRSP-EE | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 1, Day 11 (n=30 NOMAC-E2 / n=16 DRSP-EE) | 1.89 IU/L | Standard Deviation 1.45 |
| DRSP-EE | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 1, Day 2 (n=32 NOMAC-E2 / n=16 DRSP-EE) | 3.69 IU/L | Standard Deviation 1.58 |
| DRSP-EE | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 2, Day 2 (n=29 NOMAC-E2 / n=16 DRSP-EE) | 4.81 IU/L | Standard Deviation 3.01 |
| DRSP-EE | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 2, Day 21 (n=27 NOMAC-E2 / n=16 DRSP-EE) | 0.97 IU/L | Standard Deviation 0.67 |
| DRSP-EE | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 1, Day 14 (n=29 NOMAC-E2 / n=16 DRSP-EE) | 2.32 IU/L | Standard Deviation 2.05 |
| DRSP-EE | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 2, Day 24 (n=27 NOMAC-E2 / n=16 DRSP-EE) | 2.38 IU/L | Standard Deviation 2.01 |
| DRSP-EE | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 2, Day 11 (n=29 NOMAC-E2 / n=16 DRSP-EE) | 2.70 IU/L | Standard Deviation 2.18 |
| DRSP-EE | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 2, Day 27 (n=27 NOMAC-E2 / n=16 DRSP-EE) | 3.92 IU/L | Standard Deviation 2.17 |
| DRSP-EE | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 1, Day 18 (n=29 NOMAC-E2 / n=16 DRSP-EE) | 1.61 IU/L | Standard Deviation 1.29 |
| DRSP-EE | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 3, Day 2 (n=27 NOMAC-E2 / n=14 DRSP-EE) | 4.79 IU/L | Standard Deviation 2.67 |
| DRSP-EE | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 2, Day 5 (n=29 NOMAC-E2 / n=15 DRSP-EE) | 5.08 IU/L | Standard Deviation 3.21 |
| DRSP-EE | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 6, Day 14 (n=25 NOMAC-E2 / n=14 DRSP-EE) | 2.15 IU/L | Standard Deviation 2.83 |
| DRSP-EE | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 1, Day 21 (n=30 NOMAC-E2 / n=16 DRSP-EE) | 1.19 IU/L | Standard Deviation 0.86 |
| DRSP-EE | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 6, Day 18 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 1.27 IU/L | Standard Deviation 1.02 |
| DRSP-EE | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 2, Day 18 (n=28 NOMAC-E2 / n=15 DRSP-EE) | 1.60 IU/L | Standard Deviation 1.31 |
| DRSP-EE | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 6, Day 21 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 1.14 IU/L | Standard Deviation 0.89 |
| DRSP-EE | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 1, Day 24 (n=30 NOMAC-E2 / n=16 DRSP-EE) | 2.63 IU/L | Standard Deviation 2.07 |
| DRSP-EE | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 6, Day 24 (n=26 NOMAC-E2 / n=14 DRSP-EE) | 2.56 IU/L | Standard Deviation 2.12 |
| DRSP-EE | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 2, Day 8 (n=29 NOMAC-E2 / n=16 DRSP-EE) | 3.33 IU/L | Standard Deviation 1.97 |
| DRSP-EE | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 6, Day 27 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 4.03 IU/L | Standard Deviation 2.57 |
| DRSP-EE | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 1, Day 5 (n=32 NOMAC-E2 / n=16 DRSP-EE) | 4.34 IU/L | Standard Deviation 2.35 |
| DRSP-EE | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 1, Day 27 (n=30 NOMAC-E2 / n=16 DRSP-EE) | 4.34 IU/L | Standard Deviation 2.38 |
| DRSP-EE | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 1, Day 8 (n=32 NOMAC-E2 / n=16 DRSP-EE) | 3.09 IU/L | Standard Deviation 2.36 |
| DRSP-EE | Effect on Ovarian Function as Determined by Luteinizing Hormone (LH) | Cycle 2, Day 14 (n=29 NOMAC-E2 / n=15 DRSP-EE) | 1.69 IU/L | Standard Deviation 1.42 |
Primary
Effect on Ovarian Function as Determined by the Maximum Follicle Diameter
The maximum follicular diameter was defined as the largest follicular diameter during a treatment cycle.
Time frame: Screening cycle, Cycle 1, Cycle 2, Cycle 3, and Cycle 6
Population: ITT group consisted of all participants who were treated.~n=number of participants completing the respective cycle with non-missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Effect on Ovarian Function as Determined by the Maximum Follicle Diameter | Cycle 1 (n=32 NOMAC-E2 / n=16 DRSP-EE) | 7.6 millimeters (mm) | Standard Deviation 1.51 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by the Maximum Follicle Diameter | Cycle 3 (n=27 NOMAC-E2 / n=14 DRSP-EE) | 7.8 millimeters (mm) | Standard Deviation 1.88 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by the Maximum Follicle Diameter | Cycle 2 (n=29 NOMAC-E2 / n=16 DRSP-EE) | 8.2 millimeters (mm) | Standard Deviation 1.82 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by the Maximum Follicle Diameter | Cycle 6 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 6.9 millimeters (mm) | Standard Deviation 2.07 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by the Maximum Follicle Diameter | Screening cycle (n=32 NOMAC-E2 / n=16 DRSP-EE) | 19.3 millimeters (mm) | Standard Deviation 3.13 |
| DRSP-EE | Effect on Ovarian Function as Determined by the Maximum Follicle Diameter | Cycle 6 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 7.4 millimeters (mm) | Standard Deviation 2.06 |
| DRSP-EE | Effect on Ovarian Function as Determined by the Maximum Follicle Diameter | Screening cycle (n=32 NOMAC-E2 / n=16 DRSP-EE) | 19.6 millimeters (mm) | Standard Deviation 4.32 |
| DRSP-EE | Effect on Ovarian Function as Determined by the Maximum Follicle Diameter | Cycle 1 (n=32 NOMAC-E2 / n=16 DRSP-EE) | 8.1 millimeters (mm) | Standard Deviation 1.98 |
| DRSP-EE | Effect on Ovarian Function as Determined by the Maximum Follicle Diameter | Cycle 2 (n=29 NOMAC-E2 / n=16 DRSP-EE) | 10.8 millimeters (mm) | Standard Deviation 4.76 |
| DRSP-EE | Effect on Ovarian Function as Determined by the Maximum Follicle Diameter | Cycle 3 (n=27 NOMAC-E2 / n=14 DRSP-EE) | 8.4 millimeters (mm) | Standard Deviation 2.31 |
Primary
Effect on Ovarian Function as Determined by the Maximum Progesterone Value
The maximum progesterone value was defined as the largest value during a cycle.
Time frame: Screening cycle, Cycle 1, Cycle 2, Cycle 3, and Cycle 6
Population: ITT group consisted of all participants who were treated.~n=number of participants completing the respective cycle with non-missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Effect on Ovarian Function as Determined by the Maximum Progesterone Value | Cycle 3 (n=27 NOMAC-E2 / n=14 DRSP-EE) | 1.26 nanomoles per liter (nmol/L) | Standard Deviation 0.1 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by the Maximum Progesterone Value | Cycle 6 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 1.3 nanomoles per liter (nmol/L) | Standard Deviation 0.29 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by the Maximum Progesterone Value | Screening cycle (n=32 NOMAC-E2 / n=16 DRSP-EE) | 38.7 nanomoles per liter (nmol/L) | Standard Deviation 12.62 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by the Maximum Progesterone Value | Cycle 1 (n=32 NOMAC-E2 / n=16 DRSP-EE) | 1.7 nanomoles per liter (nmol/L) | Standard Deviation 0.46 |
| NOMAC-E2 | Effect on Ovarian Function as Determined by the Maximum Progesterone Value | Cycle 2 (n=29 NOMAC-E2 / n=16 DRSP-EE) | 1.5 nanomoles per liter (nmol/L) | Standard Deviation 0.46 |
| DRSP-EE | Effect on Ovarian Function as Determined by the Maximum Progesterone Value | Cycle 2 (n=29 NOMAC-E2 / n=16 DRSP-EE) | 1.5 nanomoles per liter (nmol/L) | Standard Deviation 0.26 |
| DRSP-EE | Effect on Ovarian Function as Determined by the Maximum Progesterone Value | Cycle 1 (n=32 NOMAC-E2 / n=16 DRSP-EE) | 1.6 nanomoles per liter (nmol/L) | Standard Deviation 0.28 |
| DRSP-EE | Effect on Ovarian Function as Determined by the Maximum Progesterone Value | Cycle 6 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 1.5 nanomoles per liter (nmol/L) | Standard Deviation 0.26 |
| DRSP-EE | Effect on Ovarian Function as Determined by the Maximum Progesterone Value | Cycle 3 (n=27 NOMAC-E2 / n=14 DRSP-EE) | 1.34 nanomoles per liter (nmol/L) | Standard Deviation 0.27 |
| DRSP-EE | Effect on Ovarian Function as Determined by the Maximum Progesterone Value | Screening cycle (n=32 NOMAC-E2 / n=16 DRSP-EE) | 38.7 nanomoles per liter (nmol/L) | Standard Deviation 17.01 |
Primary
Effect on Ovarian Function as Determined by the Number of Participants With an Occurrence of Ovulation
During treatment, ovulation was assessed for each participant by the investigator on the basis of ultrasound scanning (USS). The final analysis was based on assessor-blind adjudication.
Time frame: Cycle 1, Cycle 2, and Cycle 6
Population: Intent-to-treat (ITT) group consisted of all participants who were treated.~n=number of participants completing the respective cycle with non-missing values.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NOMAC-E2 | Effect on Ovarian Function as Determined by the Number of Participants With an Occurrence of Ovulation | Cycle 1 (n=32 NOMAC-E2 / n=16 DRSP-EE) | 0 Participants |
| NOMAC-E2 | Effect on Ovarian Function as Determined by the Number of Participants With an Occurrence of Ovulation | Cycle 2 (n=29 NOMAC-E2 / n=16 DRSP-EE) | 0 Participants |
| NOMAC-E2 | Effect on Ovarian Function as Determined by the Number of Participants With an Occurrence of Ovulation | Cycle 6 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 0 Participants |
| DRSP-EE | Effect on Ovarian Function as Determined by the Number of Participants With an Occurrence of Ovulation | Cycle 1 (n=32 NOMAC-E2 / n=16 DRSP-EE) | 0 Participants |
| DRSP-EE | Effect on Ovarian Function as Determined by the Number of Participants With an Occurrence of Ovulation | Cycle 2 (n=29 NOMAC-E2 / n=16 DRSP-EE) | 0 Participants |
| DRSP-EE | Effect on Ovarian Function as Determined by the Number of Participants With an Occurrence of Ovulation | Cycle 6 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 0 Participants |
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 card 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: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.
Time frame: Every 28-day cycle for 6 cycles
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Average Number of Breakthrough Bleeding/Spotting Days | Cycle 1 (n=7 NOMAC-E2; n=1 DRSP-EE) | 3.0 Days | Standard Deviation 2.2 |
| NOMAC-E2 | Average Number of Breakthrough Bleeding/Spotting Days | Cycle 2 (n=6 NOMAC-E2; n=0 DRSP-EE) | 2.7 Days | Standard Deviation 1.9 |
| NOMAC-E2 | Average Number of Breakthrough Bleeding/Spotting Days | Cycle 3 (n=5 NOMAC-E2; n=0 DRSP-EE) | 2.2 Days | Standard Deviation 1.1 |
| NOMAC-E2 | Average Number of Breakthrough Bleeding/Spotting Days | Cycle 4 (n=5 NOMAC-E2; n=0 DRSP-EE) | 4.0 Days | Standard Deviation 2.8 |
| NOMAC-E2 | Average Number of Breakthrough Bleeding/Spotting Days | Cycle 5 (n=8 NOMAC-E2; n=0 DRSP-EE) | 3.5 Days | Standard Deviation 2.3 |
| NOMAC-E2 | Average Number of Breakthrough Bleeding/Spotting Days | Cycle 6 (n=5 NOMAC-E2; n=0 DRSP-EE) | 3.6 Days | Standard Deviation 2.1 |
| DRSP-EE | Average Number of Breakthrough Bleeding/Spotting Days | Cycle 5 (n=8 NOMAC-E2; n=0 DRSP-EE) | NA Days | — |
| DRSP-EE | Average Number of Breakthrough Bleeding/Spotting Days | Cycle 1 (n=7 NOMAC-E2; n=1 DRSP-EE) | 2.0 Days | — |
| DRSP-EE | Average Number of Breakthrough Bleeding/Spotting Days | Cycle 4 (n=5 NOMAC-E2; n=0 DRSP-EE) | NA Days | — |
| DRSP-EE | Average Number of Breakthrough Bleeding/Spotting Days | Cycle 2 (n=6 NOMAC-E2; n=0 DRSP-EE) | NA Days | — |
| DRSP-EE | Average Number of Breakthrough Bleeding/Spotting Days | Cycle 6 (n=5 NOMAC-E2; n=0 DRSP-EE) | NA Days | — |
| DRSP-EE | Average Number of Breakthrough Bleeding/Spotting Days | Cycle 3 (n=5 NOMAC-E2; n=0 DRSP-EE) | NA Days | — |
Secondary
Average Number of Withdrawal Bleeding Days
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. 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: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle.
Time frame: Every 28-day cycle for 6 cycles
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Average Number of Withdrawal Bleeding Days | Cycle 3 (n=24 NOMAC-E2; n=15 DRSP-EE) | 4.3 Days | Standard Deviation 2.4 |
| NOMAC-E2 | Average Number of Withdrawal Bleeding Days | Cycle 6 (n=22 NOMAC-E2; n=13 DRSP-EE) | 5.2 Days | Standard Deviation 6.3 |
| NOMAC-E2 | Average Number of Withdrawal Bleeding Days | Cycle 1 (n=25 NOMAC-E2; n=16 DRSP-EE) | 7.4 Days | Standard Deviation 7.5 |
| NOMAC-E2 | Average Number of Withdrawal Bleeding Days | Cycle 1 (n=27 NOMAC-E2; n=16 DRSP-EE) | 7.2 Days | Standard Deviation 6.7 |
| NOMAC-E2 | Average Number of Withdrawal Bleeding Days | Cycle 4 (n=24 NOMAC-E2; n=15 DRSP-EE) | 4.7 Days | Standard Deviation 1.9 |
| NOMAC-E2 | Average Number of Withdrawal Bleeding Days | Cycle 5 (n=24 NOMAC-E2; n=15 DRSP-EE) | 5.5 Days | Standard Deviation 6.1 |
| DRSP-EE | Average Number of Withdrawal Bleeding Days | Cycle 4 (n=24 NOMAC-E2; n=15 DRSP-EE) | 5.3 Days | Standard Deviation 1 |
| DRSP-EE | Average Number of Withdrawal Bleeding Days | Cycle 1 (n=25 NOMAC-E2; n=16 DRSP-EE) | 5.0 Days | Standard Deviation 1.7 |
| DRSP-EE | Average Number of Withdrawal Bleeding Days | Cycle 3 (n=24 NOMAC-E2; n=15 DRSP-EE) | 5.4 Days | Standard Deviation 1.5 |
| DRSP-EE | Average Number of Withdrawal Bleeding Days | Cycle 5 (n=24 NOMAC-E2; n=15 DRSP-EE) | 4.9 Days | Standard Deviation 1.1 |
| DRSP-EE | Average Number of Withdrawal Bleeding Days | Cycle 6 (n=22 NOMAC-E2; n=13 DRSP-EE) | 3.9 Days | Standard Deviation 0.9 |
| DRSP-EE | Average Number of Withdrawal Bleeding Days | Cycle 1 (n=27 NOMAC-E2; n=16 DRSP-EE) | 7.0 Days | Standard Deviation 4.7 |
Secondary
Effect on Cervical Mucus as Determined by Insler Score
The Insler Score was assessed on Day 6 after ovulation during the Screening Cycle, on Day 21 of Cycle 1, and when the maximum follicle diameter was greater than or equal to 15 mm. The Insler Score consisted of four categories each scaled from 0 (none) to 3 (complete). The higher the score, the greater the cervical reaction.
Time frame: Screening Cycle, Cycle 1, Cycle 2, and Cycle 7 (post-treatment cycle)
Population: ITT group consisted of all participants who were treated.~n=number of participants with non-missing values at the respective time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Effect on Cervical Mucus as Determined by Insler Score | Screening cycle (n=32 NOMAC-E2 / n=16 DRSP-EE) | 8.9 score on a scale | Standard Deviation 2.55 |
| NOMAC-E2 | Effect on Cervical Mucus as Determined by Insler Score | Cycle 1 (n=30 NOMAC-E2 / n=15 DRSP-EE) | 2.3 score on a scale | Standard Deviation 1.93 |
| NOMAC-E2 | Effect on Cervical Mucus as Determined by Insler Score | Cycle 2 (n=0 NOMAC-E2 / n=2 DRSP-EE) | NA score on a scale | — |
| NOMAC-E2 | Effect on Cervical Mucus as Determined by Insler Score | Cycle 7 (n=22 NOMAC-E2 / n=15 DRSP-EE) | 7.0 score on a scale | Standard Deviation 2.94 |
| DRSP-EE | Effect on Cervical Mucus as Determined by Insler Score | Cycle 7 (n=22 NOMAC-E2 / n=15 DRSP-EE) | 8.7 score on a scale | Standard Deviation 1.53 |
| DRSP-EE | Effect on Cervical Mucus as Determined by Insler Score | Screening cycle (n=32 NOMAC-E2 / n=16 DRSP-EE) | 7.3 score on a scale | Standard Deviation 3.61 |
| DRSP-EE | Effect on Cervical Mucus as Determined by Insler Score | Cycle 2 (n=0 NOMAC-E2 / n=2 DRSP-EE) | 4.5 score on a scale | Standard Deviation 0.71 |
| DRSP-EE | Effect on Cervical Mucus as Determined by Insler Score | Cycle 1 (n=30 NOMAC-E2 / n=15 DRSP-EE) | 3.2 score on a scale | Standard Deviation 2.43 |
Secondary
Effect on Maximum Endometrial Thickness
Maximum endometrial thickness was defined as the largest endometrial thickness during a cycle.
Time frame: Screening Cycle, Cycle 1, Cycle 2, and Cycle 6
Population: ITT group consisted of all participants who were treated.~n=number of participants completing the respective cycle.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Effect on Maximum Endometrial Thickness | Screening cycle (n=32 NOMAC-E2 / n=16 DRSP-EE) | 9.9 mm | Standard Deviation 1.91 |
| NOMAC-E2 | Effect on Maximum Endometrial Thickness | Cycle 1 (n=32 NOMAC-E2 / n=16 DRSP-EE) | 5.9 mm | Standard Deviation 1.22 |
| NOMAC-E2 | Effect on Maximum Endometrial Thickness | Cycle 2 (n=29 NOMAC-E2 / n=16 DRSP-EE) | 5.3 mm | Standard Deviation 0.71 |
| NOMAC-E2 | Effect on Maximum Endometrial Thickness | Cycle 6 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 4.9 mm | Standard Deviation 0.66 |
| DRSP-EE | Effect on Maximum Endometrial Thickness | Cycle 6 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 5.5 mm | Standard Deviation 1.3 |
| DRSP-EE | Effect on Maximum Endometrial Thickness | Screening cycle (n=32 NOMAC-E2 / n=16 DRSP-EE) | 10.1 mm | Standard Deviation 2.5 |
| DRSP-EE | Effect on Maximum Endometrial Thickness | Cycle 2 (n=29 NOMAC-E2 / n=16 DRSP-EE) | 6.8 mm | Standard Deviation 1.73 |
| DRSP-EE | Effect on Maximum Endometrial Thickness | Cycle 1 (n=32 NOMAC-E2 / n=16 DRSP-EE) | 6.1 mm | Standard Deviation 1.25 |
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 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 woman years) that the women were under risk of becoming pregnant.
Time frame: 6 cycles
Population: 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 without sexual intercourse per diary card data).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NOMAC-E2 | Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) | 0 Pregnancies per 100 woman years |
| DRSP-EE | Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) | 0 Pregnancies per 100 woman 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 card 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: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle.
Time frame: Every 28-day cycle for 6 cycles
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NOMAC-E2 | Number of Participants With an Occurrence of Absence of Withdrawal Bleeding | Cycle 3 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 2 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Absence of Withdrawal Bleeding | Cycle 1 (n=30 NOMAC-E2 / n=16 DRSP-EE) | 3 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Absence of Withdrawal Bleeding | Cycle 2 (n=27 NOMAC-E2 / n=16 DRSP-EE) | 2 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Absence of Withdrawal Bleeding | Cycle 4 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 2 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Absence of Withdrawal Bleeding | Cycle 5 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 2 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Absence of Withdrawal Bleeding | Cycle 6 (n=26 NOMAC-E2 / n=14 DRSP-EE) | 4 Participants |
| DRSP-EE | Number of Participants With an Occurrence of Absence of Withdrawal Bleeding | Cycle 3 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 0 Participants |
| DRSP-EE | Number of Participants With an Occurrence of Absence of Withdrawal Bleeding | Cycle 4 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 0 Participants |
| DRSP-EE | Number of Participants With an Occurrence of Absence of Withdrawal Bleeding | Cycle 6 (n=26 NOMAC-E2 / n=14 DRSP-EE) | 1 Participants |
| DRSP-EE | Number of Participants With an Occurrence of Absence of Withdrawal Bleeding | Cycle 1 (n=30 NOMAC-E2 / n=16 DRSP-EE) | 0 Participants |
| DRSP-EE | Number of Participants With an Occurrence of Absence of Withdrawal Bleeding | Cycle 5 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 0 Participants |
| DRSP-EE | Number of Participants With an Occurrence of Absence of Withdrawal Bleeding | Cycle 2 (n=27 NOMAC-E2 / n=16 DRSP-EE) | 0 Participants |
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 card 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: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2:21-day period starting on Day 4 of the cycle.
Time frame: Every 28-day cycle for 6 cycles
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NOMAC-E2 | Number of Participants With an Occurrence of Breakthrough Bleeding | Cycle 1 (n=30 NOMAC-E2 / n=16 DRSP-EE) | 0 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Breakthrough Bleeding | Cycle 2 (n=27 NOMAC-E2 / n=16 DRSP-EE) | 0 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Breakthrough Bleeding | Cycle 3 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 0 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Breakthrough Bleeding | Cycle 4 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 1 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Breakthrough Bleeding | Cycle 5 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 1 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Breakthrough Bleeding | Cycle 6 (n=26 NOMAC-E2 / n=14 DRSP-EE) | 0 Participants |
| DRSP-EE | Number of Participants With an Occurrence of Breakthrough Bleeding | Cycle 5 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 0 Participants |
| DRSP-EE | Number of Participants With an Occurrence of Breakthrough Bleeding | Cycle 1 (n=30 NOMAC-E2 / n=16 DRSP-EE) | 0 Participants |
| DRSP-EE | Number of Participants With an Occurrence of Breakthrough Bleeding | Cycle 4 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 0 Participants |
| DRSP-EE | Number of Participants With an Occurrence of Breakthrough Bleeding | Cycle 2 (n=27 NOMAC-E2 / n=16 DRSP-EE) | 0 Participants |
| DRSP-EE | Number of Participants With an Occurrence of Breakthrough Bleeding | Cycle 6 (n=26 NOMAC-E2 / n=14 DRSP-EE) | 0 Participants |
| DRSP-EE | Number of Participants With an Occurrence of Breakthrough Bleeding | Cycle 3 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 0 Participants |
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 card 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: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.
Time frame: Every 28-day cycle for 6 cycles
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NOMAC-E2 | Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting | Cycle 1 (n=30 NOMAC-E2 / n=16 DRSP-EE) | 7 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting | Cycle 2 (n=27 NOMAC-E2 / n=16 DRSP-EE) | 6 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting | Cycle 3 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 5 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting | Cycle 4 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 5 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting | Cycle 5 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 8 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting | Cycle 6 (n=26 NOMAC-E2 / n=14 DRSP-EE) | 5 Participants |
| DRSP-EE | Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting | Cycle 5 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 0 Participants |
| DRSP-EE | Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting | Cycle 1 (n=30 NOMAC-E2 / n=16 DRSP-EE) | 1 Participants |
| DRSP-EE | Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting | Cycle 4 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 0 Participants |
| DRSP-EE | Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting | Cycle 2 (n=27 NOMAC-E2 / n=16 DRSP-EE) | 0 Participants |
| DRSP-EE | Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting | Cycle 6 (n=26 NOMAC-E2 / n=14 DRSP-EE) | 0 Participants |
| DRSP-EE | Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting | Cycle 3 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 0 Participants |
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 card 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: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2:21-day period starting on Day 4 of the cycle.
Time frame: Every 28-day cycle for 6 cycles
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NOMAC-E2 | Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only) | Cycle 4 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 4 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only) | Cycle 5 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 7 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only) | Cycle 6 (n=26 NOMAC-E2 / n=14 DRSP-EE) | 5 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only) | Cycle 1 (n=30 NOMAC-E2 / n=16 DRSP-EE) | 7 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only) | Cycle 2 (n=27 NOMAC-E2 / n=16 DRSP-EE) | 6 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only) | Cycle 3 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 5 Participants |
| DRSP-EE | Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only) | Cycle 2 (n=27 NOMAC-E2 / n=16 DRSP-EE) | 0 Participants |
| DRSP-EE | Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only) | Cycle 1 (n=30 NOMAC-E2 / n=16 DRSP-EE) | 1 Participants |
| DRSP-EE | Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only) | Cycle 4 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 0 Participants |
| DRSP-EE | Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only) | Cycle 5 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 0 Participants |
| DRSP-EE | Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only) | Cycle 3 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 0 Participants |
| DRSP-EE | Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only) | Cycle 6 (n=26 NOMAC-E2 / n=14 DRSP-EE) | 0 Participants |
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 card 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: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.
Time frame: Every 28-day cycle for 5 cycles
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NOMAC-E2 | Number of Participants With an Occurrence of Continued Withdrawal Bleeding | Cycle 3 (n=25 NOMAC-E2 / n=15 DRSP-EE) | 8 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Continued Withdrawal Bleeding | Cycle 4 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 12 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Continued Withdrawal Bleeding | Cycle 2 (n=27 NOMAC-E2 / n=16 DRSP-EE) | 8 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Continued Withdrawal Bleeding | Cycle 5 (n=26 NOMAC-E2 / n=14 DRSP-EE) | 9 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Continued Withdrawal Bleeding | Cycle 1 (n=29 NOMAC-E2 / n=16 DRSP-EE) | 11 Participants |
| DRSP-EE | Number of Participants With an Occurrence of Continued Withdrawal Bleeding | Cycle 5 (n=26 NOMAC-E2 / n=14 DRSP-EE) | 10 Participants |
| DRSP-EE | Number of Participants With an Occurrence of Continued Withdrawal Bleeding | Cycle 1 (n=29 NOMAC-E2 / n=16 DRSP-EE) | 12 Participants |
| DRSP-EE | Number of Participants With an Occurrence of Continued Withdrawal Bleeding | Cycle 2 (n=27 NOMAC-E2 / n=16 DRSP-EE) | 10 Participants |
| DRSP-EE | Number of Participants With an Occurrence of Continued Withdrawal Bleeding | Cycle 4 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 12 Participants |
| DRSP-EE | Number of Participants With an Occurrence of Continued Withdrawal Bleeding | Cycle 3 (n=25 NOMAC-E2 / n=15 DRSP-EE) | 11 Participants |
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 card 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: DRSP-EE: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle.
Time frame: Every 28-day cycle for 6 cycles
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NOMAC-E2 | Number of Participants With an Occurrence of Early Withdrawal Bleeding | Cycle 4 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 2 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Early Withdrawal Bleeding | Cycle 6 (n=26 NOMAC-E2 / n=14 DRSP-EE) | 2 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Early Withdrawal Bleeding | Cycle 1 (n=30 NOMAC-E2 / n=16 DRSP-EE) | 4 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Early Withdrawal Bleeding | Cycle 2 (n=27 NOMAC-E2 / n=16 DRSP-EE) | 4 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Early Withdrawal Bleeding | Cycle 3 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 1 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Early Withdrawal Bleeding | Cycle 5 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 1 Participants |
| DRSP-EE | Number of Participants With an Occurrence of Early Withdrawal Bleeding | Cycle 5 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 0 Participants |
| DRSP-EE | Number of Participants With an Occurrence of Early Withdrawal Bleeding | Cycle 3 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 0 Participants |
| DRSP-EE | Number of Participants With an Occurrence of Early Withdrawal Bleeding | Cycle 4 (n=26 NOMAC-E2 / n=15 DRSP-EE) | 0 Participants |
| DRSP-EE | Number of Participants With an Occurrence of Early Withdrawal Bleeding | Cycle 1 (n=30 NOMAC-E2 / n=16 DRSP-EE) | 2 Participants |
| DRSP-EE | Number of Participants With an Occurrence of Early Withdrawal Bleeding | Cycle 6 (n=26 NOMAC-E2 / n=14 DRSP-EE) | 0 Participants |
| DRSP-EE | Number of Participants With an Occurrence of Early Withdrawal Bleeding | Cycle 2 (n=27 NOMAC-E2 / n=16 DRSP-EE) | 0 Participants |