Trial Outcomes & Findings for Effects on Ovarian Function of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing DRSP/EE (292003)(COMPLETED)(P05723) (NCT NCT00511433)
NCT ID: NCT00511433
Last Updated: 2022-02-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
48 participants
Primary outcome timeframe
Cycle 1, Cycle 2, and Cycle 6
Results posted on
2022-02-09
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
16
|
|
Overall Study
COMPLETED
|
26
|
15
|
|
Overall Study
NOT COMPLETED
|
6
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
0
|
|
Overall Study
Other Reason
|
1
|
1
|
Baseline Characteristics
Effects on Ovarian Function of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing DRSP/EE (292003)(COMPLETED)(P05723)
Baseline characteristics by cohort
| Measure |
NOMAC-E2
n=32 Participants
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.
|
DRSP-EE
n=16 Participants
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.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
22.8 years
STANDARD_DEVIATION 3.3 • n=5 Participants
|
22.9 years
STANDARD_DEVIATION 4.3 • n=7 Participants
|
22.8 years
STANDARD_DEVIATION 3.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Cycle 1, Cycle 2, and Cycle 6Population: Intent-to-treat (ITT) group consisted of all participants who were treated. n=number of participants completing the respective cycle with non-missing values.
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.
Outcome measures
| Measure |
NOMAC-E2
n=32 Participants
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.
|
DRSP-EE
n=16 Participants
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.
|
|---|---|---|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
PRIMARY outcome
Timeframe: Screening cycle, Cycle 1, Cycle 2, Cycle 3, and Cycle 6Population: ITT group consisted of all participants who were treated. n=number of participants completing the respective cycle with non-missing values.
The maximum follicular diameter was defined as the largest follicular diameter during a treatment cycle.
Outcome measures
| Measure |
NOMAC-E2
n=32 Participants
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.
|
DRSP-EE
n=16 Participants
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.
|
|---|---|---|
|
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
|
19.6 millimeters (mm)
Standard Deviation 4.32
|
|
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
|
8.1 millimeters (mm)
Standard Deviation 1.98
|
|
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
|
10.8 millimeters (mm)
Standard Deviation 4.76
|
|
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
|
8.4 millimeters (mm)
Standard Deviation 2.31
|
|
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
|
7.4 millimeters (mm)
Standard Deviation 2.06
|
PRIMARY outcome
Timeframe: Screening cycle, Cycle 1, Cycle 2, Cycle 3, and Cycle 6Population: ITT group consisted of all participants who were treated. n=number of participants completing the respective cycle with non-missing values.
The maximum progesterone value was defined as the largest value during a cycle.
Outcome measures
| Measure |
NOMAC-E2
n=32 Participants
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.
|
DRSP-EE
n=16 Participants
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.
|
|---|---|---|
|
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
|
38.7 nanomoles per liter (nmol/L)
Standard Deviation 17.01
|
|
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
|
1.6 nanomoles per liter (nmol/L)
Standard Deviation 0.28
|
|
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
|
1.5 nanomoles per liter (nmol/L)
Standard Deviation 0.26
|
|
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 0.10
|
1.34 nanomoles per liter (nmol/L)
Standard Deviation 0.27
|
|
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
|
1.5 nanomoles per liter (nmol/L)
Standard Deviation 0.26
|
PRIMARY outcome
Timeframe: Cycle 1, Cycle 2, Cycle 3, and Cycle 6Population: ITT group consisted of all participants who were treated. n=number of participants with non-missing values at the respective time point.
The parameter was measured at pre-defined study days.
Outcome measures
| Measure |
NOMAC-E2
n=32 Participants
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.
|
DRSP-EE
n=16 Participants
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.
|
|---|---|---|
|
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
|
79.82 picomoles per liter (pmol/L)
Standard Deviation 18.34
|
|
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
|
66.66 picomoles per liter (pmol/L)
Standard Deviation 10.53
|
|
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
|
61.15 picomoles per liter (pmol/L)
Standard Deviation 3.66
|
|
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 95.70
|
60.51 picomoles per liter (pmol/L)
Standard Deviation 1.96
|
|
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
|
60.26 picomoles per liter (pmol/L)
Standard Deviation 1.48
|
|
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
|
60.58 picomoles per liter (pmol/L)
Standard Deviation 2.93
|
|
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 139.50
|
59.82 picomoles per liter (pmol/L)
Standard Deviation 0
|
|
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
|
69.84 picomoles per liter (pmol/L)
Standard Deviation 23.50
|
|
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
|
150.79 picomoles per liter (pmol/L)
Standard Deviation 46.45
|
|
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
|
135.86 picomoles per liter (pmol/L)
Standard Deviation 106.62
|
|
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
|
142.74 picomoles per liter (pmol/L)
Standard Deviation 186.99
|
|
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
|
131.98 picomoles per liter (pmol/L)
Standard Deviation 196.51
|
|
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
|
112.23 picomoles per liter (pmol/L)
Standard Deviation 152.19
|
|
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
|
78.44 picomoles per liter (pmol/L)
Standard Deviation 69.99
|
|
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
|
60.11 picomoles per liter (pmol/L)
Standard Deviation 0.95
|
|
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
|
59.91 picomoles per liter (pmol/L)
Standard Deviation 0.37
|
|
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
|
61.33 picomoles per liter (pmol/L)
Standard Deviation 3.95
|
|
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
|
155.63 picomoles per liter (pmol/L)
Standard Deviation 63.65
|
|
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
|
141.11 picomoles per liter (pmol/L)
Standard Deviation 115.89
|
|
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
|
59.98 picomoles per liter (pmol/L)
Standard Deviation 0.59
|
|
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
|
64.20 picomoles per liter (pmol/L)
Standard Deviation 12.99
|
|
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
|
60.82 picomoles per liter (pmol/L)
Standard Deviation 3.02
|
|
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 106.60
|
69.60 picomoles per liter (pmol/L)
Standard Deviation 33.97
|
|
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 35.60
|
133.49 picomoles per liter (pmol/L)
Standard Deviation 61.28
|
PRIMARY outcome
Timeframe: Cycle 1, Cycle 2, Cycle 3, and Cycle 6Population: ITT group consisted of all participants who were treated. n=number of participants with non-missing values at the respective time point.
The parameter was measured at pre-defined study days.
Outcome measures
| Measure |
NOMAC-E2
n=32 Participants
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.
|
DRSP-EE
n=16 Participants
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.
|
|---|---|---|
|
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
|
1.43 International units per liter (IU/L)
Standard Deviation 1.32
|
|
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
|
4.51 International units per liter (IU/L)
Standard Deviation 1.14
|
|
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
|
4.23 International units per liter (IU/L)
Standard Deviation 1.33
|
|
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
|
3.40 International units per liter (IU/L)
Standard Deviation 1.57
|
|
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
|
2.46 International units per liter (IU/L)
Standard Deviation 1.40
|
|
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 1.90
|
2.32 International units per liter (IU/L)
Standard Deviation 1.71
|
|
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
|
1.91 International units per liter (IU/L)
Standard Deviation 1.69
|
|
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
|
1.61 International units per liter (IU/L)
Standard Deviation 1.53
|
|
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
|
4.50 International units per liter (IU/L)
Standard Deviation 4.05
|
|
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
|
7.91 International units per liter (IU/L)
Standard Deviation 3.95
|
|
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
|
5.48 International units per liter (IU/L)
Standard Deviation 1.82
|
|
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
|
4.08 International units per liter (IU/L)
Standard Deviation 1.54
|
|
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
|
2.77 International units per liter (IU/L)
Standard Deviation 1.19
|
|
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
|
1.96 International units per liter (IU/L)
Standard Deviation 1.13
|
|
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
|
1.44 International units per liter (IU/L)
Standard Deviation 1.00
|
|
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
|
1.22 International units per liter (IU/L)
Standard Deviation 0.94
|
|
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
|
1.04 International units per liter (IU/L)
Standard Deviation 0.98
|
|
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
|
3.52 International units per liter (IU/L)
Standard Deviation 3.51
|
|
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
|
6.99 International units per liter (IU/L)
Standard Deviation 2.78
|
|
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
|
5.17 International units per liter (IU/L)
Standard Deviation 1.44
|
|
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
|
1.29 International units per liter (IU/L)
Standard Deviation 1.28
|
|
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
|
0.92 International units per liter (IU/L)
Standard Deviation 0.96
|
|
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
|
3.18 International units per liter (IU/L)
Standard Deviation 3.04
|
|
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
|
6.22 International units per liter (IU/L)
Standard Deviation 2.99
|
PRIMARY outcome
Timeframe: Cycle 1, Cycle 2, Cycle 3, and Cycle 6Population: ITT group consisted of all participants who were treated. n=number of participants with non-missing values at the respective time point.
The parameter was measured at pre-defined study days.
Outcome measures
| Measure |
NOMAC-E2
n=32 Participants
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.
|
DRSP-EE
n=16 Participants
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.
|
|---|---|---|
|
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
|
3.69 IU/L
Standard Deviation 1.58
|
|
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
|
4.34 IU/L
Standard Deviation 2.35
|
|
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
|
3.09 IU/L
Standard Deviation 2.36
|
|
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 1.50
|
1.89 IU/L
Standard Deviation 1.45
|
|
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
|
2.32 IU/L
Standard Deviation 2.05
|
|
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
|
1.61 IU/L
Standard Deviation 1.29
|
|
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
|
1.19 IU/L
Standard Deviation 0.86
|
|
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
|
2.63 IU/L
Standard Deviation 2.07
|
|
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
|
4.34 IU/L
Standard Deviation 2.38
|
|
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 2.20
|
4.81 IU/L
Standard Deviation 3.01
|
|
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
|
5.08 IU/L
Standard Deviation 3.21
|
|
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
|
3.33 IU/L
Standard Deviation 1.97
|
|
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
|
2.70 IU/L
Standard Deviation 2.18
|
|
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
|
1.69 IU/L
Standard Deviation 1.42
|
|
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
|
1.60 IU/L
Standard Deviation 1.31
|
|
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
|
0.97 IU/L
Standard Deviation 0.67
|
|
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
|
2.38 IU/L
Standard Deviation 2.01
|
|
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 2.90
|
3.92 IU/L
Standard Deviation 2.17
|
|
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
|
4.79 IU/L
Standard Deviation 2.67
|
|
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
|
2.15 IU/L
Standard Deviation 2.83
|
|
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
|
1.27 IU/L
Standard Deviation 1.02
|
|
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
|
1.14 IU/L
Standard Deviation 0.89
|
|
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
|
2.56 IU/L
Standard Deviation 2.12
|
|
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
|
4.03 IU/L
Standard Deviation 2.57
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
NOMAC-E2
n=32 Participants
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.
|
DRSP-EE
n=16 Participants
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.
|
|---|---|---|
|
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
|
7.3 score on a scale
Standard Deviation 3.61
|
|
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
|
3.2 score on a scale
Standard Deviation 2.43
|
|
Effect on Cervical Mucus as Determined by Insler Score
Cycle 2 (n=0 NOMAC-E2 / n=2 DRSP-EE)
|
NA score on a scale
Standard Deviation NA
Mean and standard deviation do not apply for zero participants.
|
4.5 score on a scale
Standard Deviation 0.71
|
|
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
|
8.7 score on a scale
Standard Deviation 1.53
|
SECONDARY outcome
Timeframe: Screening Cycle, Cycle 1, Cycle 2, and Cycle 6Population: ITT group consisted of all participants who were treated. n=number of participants completing the respective cycle.
Maximum endometrial thickness was defined as the largest endometrial thickness during a cycle.
Outcome measures
| Measure |
NOMAC-E2
n=32 Participants
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.
|
DRSP-EE
n=16 Participants
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.
|
|---|---|---|
|
Effect on Maximum Endometrial Thickness
Screening cycle (n=32 NOMAC-E2 / n=16 DRSP-EE)
|
9.9 mm
Standard Deviation 1.91
|
10.1 mm
Standard Deviation 2.50
|
|
Effect on Maximum Endometrial Thickness
Cycle 1 (n=32 NOMAC-E2 / n=16 DRSP-EE)
|
5.9 mm
Standard Deviation 1.22
|
6.1 mm
Standard Deviation 1.25
|
|
Effect on Maximum Endometrial Thickness
Cycle 2 (n=29 NOMAC-E2 / n=16 DRSP-EE)
|
5.3 mm
Standard Deviation 0.71
|
6.8 mm
Standard Deviation 1.73
|
|
Effect on Maximum Endometrial Thickness
Cycle 6 (n=26 NOMAC-E2 / n=15 DRSP-EE)
|
4.9 mm
Standard Deviation 0.66
|
5.5 mm
Standard Deviation 1.30
|
SECONDARY outcome
Timeframe: 6 cyclesPopulation: 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).
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.
Outcome measures
| Measure |
NOMAC-E2
n=8 woman years (rounded to nearest integer)
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.
|
DRSP-EE
n=5 woman years (rounded to nearest integer)
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.
|
|---|---|---|
|
Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)
|
0 Pregnancies per 100 woman years
Interval 0.0 to 45.9
|
0 Pregnancies per 100 woman years
Interval 0.0 to 72.7
|
SECONDARY outcome
Timeframe: Every 28-day cycle for 6 cyclesPopulation: 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.
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.
Outcome measures
| Measure |
NOMAC-E2
n=30 Participants
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.
|
DRSP-EE
n=16 Participants
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.
|
|---|---|---|
|
Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting
Cycle 1 (n=30 NOMAC-E2 / n=16 DRSP-EE)
|
7 Participants
|
1 Participants
|
|
Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting
Cycle 2 (n=27 NOMAC-E2 / n=16 DRSP-EE)
|
6 Participants
|
0 Participants
|
|
Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting
Cycle 3 (n=26 NOMAC-E2 / n=15 DRSP-EE)
|
5 Participants
|
0 Participants
|
|
Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting
Cycle 4 (n=26 NOMAC-E2 / n=15 DRSP-EE)
|
5 Participants
|
0 Participants
|
|
Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting
Cycle 5 (n=26 NOMAC-E2 / n=15 DRSP-EE)
|
8 Participants
|
0 Participants
|
|
Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting
Cycle 6 (n=26 NOMAC-E2 / n=14 DRSP-EE)
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Every 28-day cycle for 6 cyclesPopulation: 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.
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.
Outcome measures
| Measure |
NOMAC-E2
n=30 Participants
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.
|
DRSP-EE
n=16 Participants
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.
|
|---|---|---|
|
Number of Participants With an Occurrence of Absence of Withdrawal Bleeding
Cycle 1 (n=30 NOMAC-E2 / n=16 DRSP-EE)
|
3 Participants
|
0 Participants
|
|
Number of Participants With an Occurrence of Absence of Withdrawal Bleeding
Cycle 2 (n=27 NOMAC-E2 / n=16 DRSP-EE)
|
2 Participants
|
0 Participants
|
|
Number of Participants With an Occurrence of Absence of Withdrawal Bleeding
Cycle 3 (n=26 NOMAC-E2 / n=15 DRSP-EE)
|
2 Participants
|
0 Participants
|
|
Number of Participants With an Occurrence of Absence of Withdrawal Bleeding
Cycle 4 (n=26 NOMAC-E2 / n=15 DRSP-EE)
|
2 Participants
|
0 Participants
|
|
Number of Participants With an Occurrence of Absence of Withdrawal Bleeding
Cycle 5 (n=26 NOMAC-E2 / n=15 DRSP-EE)
|
2 Participants
|
0 Participants
|
|
Number of Participants With an Occurrence of Absence of Withdrawal Bleeding
Cycle 6 (n=26 NOMAC-E2 / n=14 DRSP-EE)
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Every 28-day cycle for 6 cyclesPopulation: 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.
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.
Outcome measures
| Measure |
NOMAC-E2
n=30 Participants
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.
|
DRSP-EE
n=16 Participants
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.
|
|---|---|---|
|
Number of Participants With an Occurrence of Breakthrough Bleeding
Cycle 1 (n=30 NOMAC-E2 / n=16 DRSP-EE)
|
0 Participants
|
0 Participants
|
|
Number of Participants With an Occurrence of Breakthrough Bleeding
Cycle 2 (n=27 NOMAC-E2 / n=16 DRSP-EE)
|
0 Participants
|
0 Participants
|
|
Number of Participants With an Occurrence of Breakthrough Bleeding
Cycle 3 (n=26 NOMAC-E2 / n=15 DRSP-EE)
|
0 Participants
|
0 Participants
|
|
Number of Participants With an Occurrence of Breakthrough Bleeding
Cycle 4 (n=26 NOMAC-E2 / n=15 DRSP-EE)
|
1 Participants
|
0 Participants
|
|
Number of Participants With an Occurrence of Breakthrough Bleeding
Cycle 5 (n=26 NOMAC-E2 / n=15 DRSP-EE)
|
1 Participants
|
0 Participants
|
|
Number of Participants With an Occurrence of Breakthrough Bleeding
Cycle 6 (n=26 NOMAC-E2 / n=14 DRSP-EE)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Every 28-day cycle for 6 cyclesPopulation: 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.
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.
Outcome measures
| Measure |
NOMAC-E2
n=30 Participants
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.
|
DRSP-EE
n=16 Participants
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.
|
|---|---|---|
|
Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)
Cycle 1 (n=30 NOMAC-E2 / n=16 DRSP-EE)
|
7 Participants
|
1 Participants
|
|
Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)
Cycle 2 (n=27 NOMAC-E2 / n=16 DRSP-EE)
|
6 Participants
|
0 Participants
|
|
Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)
Cycle 3 (n=26 NOMAC-E2 / n=15 DRSP-EE)
|
5 Participants
|
0 Participants
|
|
Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)
Cycle 4 (n=26 NOMAC-E2 / n=15 DRSP-EE)
|
4 Participants
|
0 Participants
|
|
Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)
Cycle 5 (n=26 NOMAC-E2 / n=15 DRSP-EE)
|
7 Participants
|
0 Participants
|
|
Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)
Cycle 6 (n=26 NOMAC-E2 / n=14 DRSP-EE)
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Every 28-day cycle for 6 cyclesPopulation: 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.
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.
Outcome measures
| Measure |
NOMAC-E2
n=30 Participants
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.
|
DRSP-EE
n=16 Participants
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.
|
|---|---|---|
|
Number of Participants With an Occurrence of Early Withdrawal Bleeding
Cycle 5 (n=26 NOMAC-E2 / n=15 DRSP-EE)
|
1 Participants
|
0 Participants
|
|
Number of Participants With an Occurrence of Early Withdrawal Bleeding
Cycle 1 (n=30 NOMAC-E2 / n=16 DRSP-EE)
|
4 Participants
|
2 Participants
|
|
Number of Participants With an Occurrence of Early Withdrawal Bleeding
Cycle 2 (n=27 NOMAC-E2 / n=16 DRSP-EE)
|
4 Participants
|
0 Participants
|
|
Number of Participants With an Occurrence of Early Withdrawal Bleeding
Cycle 3 (n=26 NOMAC-E2 / n=15 DRSP-EE)
|
1 Participants
|
0 Participants
|
|
Number of Participants With an Occurrence of Early Withdrawal Bleeding
Cycle 4 (n=26 NOMAC-E2 / n=15 DRSP-EE)
|
2 Participants
|
0 Participants
|
|
Number of Participants With an Occurrence of Early Withdrawal Bleeding
Cycle 6 (n=26 NOMAC-E2 / n=14 DRSP-EE)
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Every 28-day cycle for 5 cyclesPopulation: 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.
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.
Outcome measures
| Measure |
NOMAC-E2
n=30 Participants
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.
|
DRSP-EE
n=16 Participants
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.
|
|---|---|---|
|
Number of Participants With an Occurrence of Continued Withdrawal Bleeding
Cycle 1 (n=29 NOMAC-E2 / n=16 DRSP-EE)
|
11 Participants
|
12 Participants
|
|
Number of Participants With an Occurrence of Continued Withdrawal Bleeding
Cycle 2 (n=27 NOMAC-E2 / n=16 DRSP-EE)
|
8 Participants
|
10 Participants
|
|
Number of Participants With an Occurrence of Continued Withdrawal Bleeding
Cycle 3 (n=25 NOMAC-E2 / n=15 DRSP-EE)
|
8 Participants
|
11 Participants
|
|
Number of Participants With an Occurrence of Continued Withdrawal Bleeding
Cycle 4 (n=26 NOMAC-E2 / n=15 DRSP-EE)
|
12 Participants
|
12 Participants
|
|
Number of Participants With an Occurrence of Continued Withdrawal Bleeding
Cycle 5 (n=26 NOMAC-E2 / n=14 DRSP-EE)
|
9 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Every 28-day cycle for 6 cyclesPopulation: 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.
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.
Outcome measures
| Measure |
NOMAC-E2
n=30 Participants
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.
|
DRSP-EE
n=16 Participants
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.
|
|---|---|---|
|
Average Number of Breakthrough Bleeding/Spotting Days
Cycle 1 (n=7 NOMAC-E2; n=1 DRSP-EE)
|
3.0 Days
Standard Deviation 2.2
|
2.0 Days
Standard Deviation NA
Value for one participant; therefore, standard deviation does not apply.
|
|
Average Number of Breakthrough Bleeding/Spotting Days
Cycle 2 (n=6 NOMAC-E2; n=0 DRSP-EE)
|
2.7 Days
Standard Deviation 1.9
|
NA Days
Standard Deviation NA
Mean and standard deviation do not apply for zero participants.
|
|
Average Number of Breakthrough Bleeding/Spotting Days
Cycle 3 (n=5 NOMAC-E2; n=0 DRSP-EE)
|
2.2 Days
Standard Deviation 1.1
|
NA Days
Standard Deviation NA
Mean and standard deviation do not apply for zero participants.
|
|
Average Number of Breakthrough Bleeding/Spotting Days
Cycle 4 (n=5 NOMAC-E2; n=0 DRSP-EE)
|
4.0 Days
Standard Deviation 2.8
|
NA Days
Standard Deviation NA
Mean and standard deviation do not apply for zero participants.
|
|
Average Number of Breakthrough Bleeding/Spotting Days
Cycle 5 (n=8 NOMAC-E2; n=0 DRSP-EE)
|
3.5 Days
Standard Deviation 2.3
|
NA Days
Standard Deviation NA
Mean and standard deviation do not apply for zero participants.
|
|
Average Number of Breakthrough Bleeding/Spotting Days
Cycle 6 (n=5 NOMAC-E2; n=0 DRSP-EE)
|
3.6 Days
Standard Deviation 2.1
|
NA Days
Standard Deviation NA
Mean and standard deviation do not apply for zero participants.
|
SECONDARY outcome
Timeframe: Every 28-day cycle for 6 cyclesPopulation: 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.
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.
Outcome measures
| Measure |
NOMAC-E2
n=30 Participants
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.
|
DRSP-EE
n=16 Participants
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.
|
|---|---|---|
|
Average Number of Withdrawal Bleeding Days
Cycle 1 (n=27 NOMAC-E2; n=16 DRSP-EE)
|
7.2 Days
Standard Deviation 6.7
|
7.0 Days
Standard Deviation 4.7
|
|
Average Number of Withdrawal Bleeding Days
Cycle 1 (n=25 NOMAC-E2; n=16 DRSP-EE)
|
7.4 Days
Standard Deviation 7.5
|
5.0 Days
Standard Deviation 1.7
|
|
Average Number of Withdrawal Bleeding Days
Cycle 3 (n=24 NOMAC-E2; n=15 DRSP-EE)
|
4.3 Days
Standard Deviation 2.4
|
5.4 Days
Standard Deviation 1.5
|
|
Average Number of Withdrawal Bleeding Days
Cycle 4 (n=24 NOMAC-E2; n=15 DRSP-EE)
|
4.7 Days
Standard Deviation 1.9
|
5.3 Days
Standard Deviation 1.0
|
|
Average Number of Withdrawal Bleeding Days
Cycle 5 (n=24 NOMAC-E2; n=15 DRSP-EE)
|
5.5 Days
Standard Deviation 6.1
|
4.9 Days
Standard Deviation 1.1
|
|
Average Number of Withdrawal Bleeding Days
Cycle 6 (n=22 NOMAC-E2; n=13 DRSP-EE)
|
5.2 Days
Standard Deviation 6.3
|
3.9 Days
Standard Deviation 0.9
|
Adverse Events
NOMAC-E2
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
DRSP-EE
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NOMAC-E2
n=32 participants at risk
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.
|
DRSP-EE
n=16 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Appendicitis perforated
|
3.1%
1/32 • Number of events 1
|
0.00%
0/16
|
Other adverse events
| Measure |
NOMAC-E2
n=32 participants at risk
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.
|
DRSP-EE
n=16 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
6.2%
2/32 • Number of events 2
|
0.00%
0/16
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/32
|
12.5%
2/16 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal distension
|
9.4%
3/32 • Number of events 3
|
0.00%
0/16
|
|
Gastrointestinal disorders
Abdominal pain
|
9.4%
3/32 • Number of events 3
|
0.00%
0/16
|
|
Gastrointestinal disorders
Abdominal pain lower
|
15.6%
5/32 • Number of events 6
|
18.8%
3/16 • Number of events 4
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/32
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
34.4%
11/32 • Number of events 13
|
0.00%
0/16
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/32
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
25.0%
8/32 • Number of events 11
|
18.8%
3/16 • Number of events 5
|
|
Gastrointestinal disorders
Toothache
|
9.4%
3/32 • Number of events 4
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
2/32 • Number of events 2
|
25.0%
4/16 • Number of events 5
|
|
General disorders
Fatigue
|
6.2%
2/32 • Number of events 2
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Hangover
|
15.6%
5/32 • Number of events 7
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Malaise
|
9.4%
3/32 • Number of events 3
|
6.2%
1/16 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/32
|
6.2%
1/16 • Number of events 1
|
|
Infections and infestations
Cystitis
|
12.5%
4/32 • Number of events 8
|
18.8%
3/16 • Number of events 4
|
|
Infections and infestations
Gastroenteritis
|
9.4%
3/32 • Number of events 3
|
0.00%
0/16
|
|
Infections and infestations
Influenza
|
15.6%
5/32 • Number of events 7
|
43.8%
7/16 • Number of events 7
|
|
Infections and infestations
Nasopharyngitis
|
46.9%
15/32 • Number of events 23
|
56.2%
9/16 • Number of events 12
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/32
|
6.2%
1/16 • Number of events 1
|
|
Infections and infestations
Vaginal candidiasis
|
6.2%
2/32 • Number of events 2
|
6.2%
1/16 • Number of events 1
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.00%
0/32
|
6.2%
1/16 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural pain
|
9.4%
3/32 • Number of events 3
|
0.00%
0/16
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/32
|
6.2%
1/16 • Number of events 1
|
|
Investigations
Weight decreased
|
6.2%
2/32 • Number of events 2
|
0.00%
0/16
|
|
Investigations
Weight increased
|
12.5%
4/32 • Number of events 4
|
6.2%
1/16 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
2/32 • Number of events 3
|
6.2%
1/16 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.6%
5/32 • Number of events 8
|
6.2%
1/16 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
9.4%
3/32 • Number of events 4
|
0.00%
0/16
|
|
Nervous system disorders
Headache
|
25.0%
8/32 • Number of events 17
|
25.0%
4/16 • Number of events 7
|
|
Psychiatric disorders
Affect lability
|
12.5%
4/32 • Number of events 4
|
6.2%
1/16 • Number of events 1
|
|
Psychiatric disorders
Depressed mood
|
9.4%
3/32 • Number of events 3
|
0.00%
0/16
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/32
|
6.2%
1/16 • Number of events 1
|
|
Renal and urinary disorders
Micturition urgency
|
3.1%
1/32 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
|
Reproductive system and breast disorders
Breast enlargement
|
3.1%
1/32 • Number of events 1
|
18.8%
3/16 • Number of events 3
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/32
|
25.0%
4/16 • Number of events 7
|
|
Reproductive system and breast disorders
Breast tenderness
|
6.2%
2/32 • Number of events 2
|
0.00%
0/16
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
6.2%
2/32 • Number of events 2
|
6.2%
1/16 • Number of events 1
|
|
Reproductive system and breast disorders
Pelvic pain
|
9.4%
3/32 • Number of events 4
|
12.5%
2/16 • Number of events 2
|
|
Reproductive system and breast disorders
Vaginal discharge
|
6.2%
2/32 • Number of events 2
|
6.2%
1/16 • Number of events 3
|
|
Reproductive system and breast disorders
Vaginal odour
|
0.00%
0/32
|
12.5%
2/16 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
12.5%
4/32 • Number of events 5
|
6.2%
1/16 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Acne
|
18.8%
6/32 • Number of events 6
|
6.2%
1/16 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.2%
2/32 • Number of events 2
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/32
|
6.2%
1/16 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
0.00%
0/32
|
6.2%
1/16 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/32
|
6.2%
1/16 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin odour abnormal
|
0.00%
0/32
|
6.2%
1/16 • Number of events 1
|
|
Vascular disorders
Hot flush
|
6.2%
2/32 • Number of events 2
|
0.00%
0/16
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER