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Trial record 37 of 100 for:    DROSPIRENONE AND ETHINYL ESTRADIOL

Effects on Ovarian Function of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing DRSP/EE (292003)(COMPLETED)(P05723)

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ClinicalTrials.gov Identifier: NCT00511433
Recruitment Status : Completed
First Posted : August 3, 2007
Results First Posted : August 29, 2011
Last Update Posted : November 26, 2014
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Contraception
Interventions Drug: NOMAC-E2
Drug: DRSP-EE
Enrollment 48
Recruitment Details  
Pre-assignment Details  
Arm/Group Title NOMAC-E2 DRSP-EE
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 32 16
Completed 26 15
Not Completed 6 1
Reason Not Completed
Adverse Event             5             0
Other Reason             1             1
Arm/Group Title NOMAC-E2 DRSP-EE Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 32 16 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 16 participants 48 participants
22.8  (3.3) 22.9  (4.3) 22.8  (3.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 16 participants 48 participants
Female
32
 100.0%
16
 100.0%
48
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Effect on Ovarian Function as Determined by the Number of Participants With an Occurrence of Ovulation
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description

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/Group Title NOMAC-E2 DRSP-EE
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 32 16
Measure Type: Number
Unit of Measure: Participants
Cycle 1 (n=32 NOMAC-E2 / n=16 DRSP-EE) 0 0
Cycle 2 (n=29 NOMAC-E2 / n=16 DRSP-EE) 0 0
Cycle 6 (n=26 NOMAC-E2 / n=15 DRSP-EE) 0 0
2.Primary Outcome
Title Effect on Ovarian Function as Determined by the Maximum Follicle Diameter
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description

ITT group consisted of all participants who were treated.

n=number of participants completing the respective cycle with non-missing values.

Arm/Group Title NOMAC-E2 DRSP-EE
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 32 16
Mean (Standard Deviation)
Unit of Measure: millimeters (mm)
Screening cycle (n=32 NOMAC-E2 / n=16 DRSP-EE) 19.3  (3.13) 19.6  (4.32)
Cycle 1 (n=32 NOMAC-E2 / n=16 DRSP-EE) 7.6  (1.51) 8.1  (1.98)
Cycle 2 (n=29 NOMAC-E2 / n=16 DRSP-EE) 8.2  (1.82) 10.8  (4.76)
Cycle 3 (n=27 NOMAC-E2 / n=14 DRSP-EE) 7.8  (1.88) 8.4  (2.31)
Cycle 6 (n=26 NOMAC-E2 / n=15 DRSP-EE) 6.9  (2.07) 7.4  (2.06)
3.Primary Outcome
Title Effect on Ovarian Function as Determined by the Maximum Progesterone Value
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description

ITT group consisted of all participants who were treated.

n=number of participants completing the respective cycle with non-missing values.

Arm/Group Title NOMAC-E2 DRSP-EE
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 32 16
Mean (Standard Deviation)
Unit of Measure: nanomoles per liter (nmol/L)
Screening cycle (n=32 NOMAC-E2 / n=16 DRSP-EE) 38.7  (12.62) 38.7  (17.01)
Cycle 1 (n=32 NOMAC-E2 / n=16 DRSP-EE) 1.7  (0.46) 1.6  (0.28)
Cycle 2 (n=29 NOMAC-E2 / n=16 DRSP-EE) 1.5  (0.46) 1.5  (0.26)
Cycle 3 (n=27 NOMAC-E2 / n=14 DRSP-EE) 1.26  (0.10) 1.34  (0.27)
Cycle 6 (n=26 NOMAC-E2 / n=15 DRSP-EE) 1.3  (0.29) 1.5  (0.26)
4.Primary Outcome
Title Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2)
Hide Description The parameter was measured at pre-defined study days.
Time Frame Cycle 1, Cycle 2, Cycle 3, and Cycle 6
Hide Outcome Measure Data
Hide Analysis Population Description

ITT group consisted of all participants who were treated.

n=number of participants with non-missing values at the respective time point.

Arm/Group Title NOMAC-E2 DRSP-EE
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 32 16
Mean (Standard Deviation)
Unit of Measure: picomoles per liter (pmol/L)
Cycle 1, Day 2 (n=32 NOMAC-E2 / n=16 DRSP-EE) 168.75  (62.37) 79.82  (18.34)
Cycle 1, Day 5 (n=32 NOMAC-E2 / n=16 DRSP-EE) 194.57  (93.17) 66.66  (10.53)
Cycle 1, Day 8 (n=32 NOMAC-E2 / n=16 DRSP-EE) 172.35  (66.92) 61.15  (3.66)
Cycle 1, Day 11 (n=30 NOMAC-E2 / n=16 DRSP-EE) 184.63  (95.70) 60.51  (1.96)
Cycle 1, Day 14 (n=29 NOMAC-E2 / n=16 DRSP-EE) 197.57  (123.23) 60.26  (1.48)
Cycle 1, Day 18 (n=29 NOMAC-E2 / n=16 DRSP-EE) 182.72  (84.03) 60.58  (2.93)
Cycle 1, Day 21 (n=30 NOMAC-E2 / n=16 DRSP-EE) 191.08  (139.50) 59.82  (0)
Cycle 1, Day 24 (n=30 NOMAC-E2 / n=16 DRSP-EE) 232.80  (281.15) 69.84  (23.50)
Cycle 1, Day 27 (n=30 NOMAC-E2 / n=16 DRSP-EE) 99.65  (42.53) 150.79  (46.45)
Cycle 2, Day 2 (n=29 NOMAC-E2 / n=16 DRSP-EE) 176.43  (91.99) 135.86  (106.62)
Cycle 2, Day 5 (n=29 NOMAC-E2 / n=15 DRSP-EE) 213.64  (104.85) 142.74  (186.99)
Cycle 2, Day 8 (n=29 NOMAC-E2 / n=16 DRSP-EE) 192.59  (68.83) 131.98  (196.51)
Cycle 2, Day 11 (n=29 NOMAC-E2 / n=16 DRSP-EE) 185.77  (63.97) 112.23  (152.19)
Cycle 2, Day 14 (n=29 NOMAC-E2 / n=15 DRSP-EE) 183.66  (74.39) 78.44  (69.99)
Cycle 2, Day 18 (n=28 NOMAC-E2 / n=15 DRSP-EE) 213.84  (123.35) 60.11  (0.95)
Cycle 2, Day 21 (n=27 NOMAC-E2 / n=16 DRSP-EE) 192.47  (66.43) 59.91  (0.37)
Cycle 2, Day 24 (n=27 NOMAC-E2 / n=16 DRSP-EE) 206.20  (147.27) 61.33  (3.95)
Cycle 2, Day 27 (n=27 NOMAC-E2 / n=16 DRSP-EE) 97.99  (40.88) 155.63  (63.65)
Cycle 3, Day 2 (n=27 NOMAC-E2 / n=14 DRSP-EE) 148.16  (52.09) 141.11  (115.89)
Cycle 6, Day 14 (n=25 NOMAC-E2 / n=14 DRSP-EE) 205.89  (104.45) 59.98  (0.59)
Cycle 6, Day 18 (n=26 NOMAC-E2 / n=15 DRSP-EE) 200.04  (90.28) 64.20  (12.99)
Cycle 6, Day 21 (n=26 NOMAC-E2 / n=15 DRSP-EE) 188.47  (90.12) 60.82  (3.02)
Cycle 6, Day 24 (n=26 NOMAC-E2 / n=14 DRSP-EE) 187.16  (106.60) 69.60  (33.97)
Cycle 6, Day 27 (n=26 NOMAC-E2 / n=15 DRSP-EE) 99.51  (35.60) 133.49  (61.28)
5.Primary Outcome
Title Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH)
Hide Description The parameter was measured at pre-defined study days.
Time Frame Cycle 1, Cycle 2, Cycle 3, and Cycle 6
Hide Outcome Measure Data
Hide Analysis Population Description

ITT group consisted of all participants who were treated.

n=number of participants with non-missing values at the respective time point.

Arm/Group Title NOMAC-E2 DRSP-EE
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 32 16
Mean (Standard Deviation)
Unit of Measure: International units per liter (IU/L)
Cycle 1, Day 2 (n=32 NOMAC-E2 / n=16 DRSP-EE) 4.29  (1.45) 4.51  (1.14)
Cycle 1, Day 5 (n=32 NOMAC-E2 / n=16 DRSP-EE) 4.08  (1.59) 4.23  (1.33)
Cycle 1, Day 8 (n=32 NOMAC-E2 / n=16 DRSP-EE) 3.59  (1.59) 3.40  (1.57)
Cycle 1, Day 11 (n=30 NOMAC-E2 / n=16 DRSP-EE) 3.44  (2.07) 2.46  (1.40)
Cycle 1, Day 14 (n=29 NOMAC-E2 / n=16 DRSP-EE) 3.06  (1.90) 2.32  (1.71)
Cycle 1, Day 18 (n=29 NOMAC-E2 / n=16 DRSP-EE) 2.95  (1.76) 1.91  (1.69)
Cycle 1, Day 21 (n=30 NOMAC-E2 / n=16 DRSP-EE) 2.87  (1.96) 1.61  (1.53)
Cycle 1, Day 24 (n=30 NOMAC-E2 / n=16 DRSP-EE) 2.88  (1.99) 4.50  (4.05)
Cycle 1, Day 27 (n=30 NOMAC-E2 / n=16 DRSP-EE) 5.42  (2.51) 7.91  (3.95)
Cycle 2, Day 2 (n=29 NOMAC-E2 / n=16 DRSP-EE) 5.32  (2.05) 5.48  (1.82)
Cycle 2, Day 5 (n=29 NOMAC-E2 / n=15 DRSP-EE) 4.59  (1.54) 4.08  (1.54)
Cycle 2, Day 8 (n=29 NOMAC-E2 / n=16 DRSP-EE) 3.99  (1.71) 2.77  (1.19)
Cycle 2, Day 11 (n=29 NOMAC-E2 / n=16 DRSP-EE) 3.47  (1.68) 1.96  (1.13)
Cycle 2, Day 14 (n=29 NOMAC-E2 / n=15 DRSP-EE) 3.34  (2.18) 1.44  (1.00)
Cycle 2, Day 18 (n=28 NOMAC-E2 / n=15 DRSP-EE) 3.18  (1.84) 1.22  (0.94)
Cycle 2, Day 21 (n=27 NOMAC-E2 / n=16 DRSP-EE) 3.02  (1.64) 1.04  (0.98)
Cycle 2, Day 24 (n=27 NOMAC-E2 / n=16 DRSP-EE) 3.05  (1.76) 3.52  (3.51)
Cycle 2, Day 27 (n=27 NOMAC-E2 / n=16 DRSP-EE) 5.92  (2.77) 6.99  (2.78)
Cycle 3, Day 2 (n=27 NOMAC-E2 / n=14 DRSP-EE) 6.01  (2.08) 5.17  (1.44)
Cycle 6, Day 14 (n=25 NOMAC-E2 / n=14 DRSP-EE) 3.08  (1.88) 1.43  (1.32)
Cycle 6, Day 18 (n=26 NOMAC-E2 / n=15 DRSP-EE) 2.82  (1.79) 1.29  (1.28)
Cycle 6, Day 21 (n=26 NOMAC-E2 / n=15 DRSP-EE) 3.30  (2.14) 0.92  (0.96)
Cycle 6, Day 24 (n=26 NOMAC-E2 / n=14 DRSP-EE) 2.86  (2.09) 3.18  (3.04)
Cycle 6, Day 27 (n=26 NOMAC-E2 / n=15 DRSP-EE) 5.65  (2.57) 6.22  (2.99)
6.Primary Outcome
Title Effect on Ovarian Function as Determined by Luteinizing Hormone (LH)
Hide Description The parameter was measured at pre-defined study days.
Time Frame Cycle 1, Cycle 2, Cycle 3, and Cycle 6
Hide Outcome Measure Data
Hide Analysis Population Description

ITT group consisted of all participants who were treated.

n=number of participants with non-missing values at the respective time point.

Arm/Group Title NOMAC-E2 DRSP-EE
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 32 16
Mean (Standard Deviation)
Unit of Measure: IU/L
Cycle 1, Day 2 (n=32 NOMAC-E2 / n=16 DRSP-EE) 3.73  (1.64) 3.69  (1.58)
Cycle 1, Day 5 (n=32 NOMAC-E2 / n=16 DRSP-EE) 2.98  (1.49) 4.34  (2.35)
Cycle 1, Day 8 (n=32 NOMAC-E2 / n=16 DRSP-EE) 2.50  (1.68) 3.09  (2.36)
Cycle 1, Day 11 (n=30 NOMAC-E2 / n=16 DRSP-EE) 2.13  (1.50) 1.89  (1.45)
Cycle 1, Day 14 (n=29 NOMAC-E2 / n=16 DRSP-EE) 1.85  (1.77) 2.32  (2.05)
Cycle 1, Day 18 (n=29 NOMAC-E2 / n=16 DRSP-EE) 1.76  (1.41) 1.61  (1.29)
Cycle 1, Day 21 (n=30 NOMAC-E2 / n=16 DRSP-EE) 1.45  (1.33) 1.19  (0.86)
Cycle 1, Day 24 (n=30 NOMAC-E2 / n=16 DRSP-EE) 1.59  (1.44) 2.63  (2.07)
Cycle 1, Day 27 (n=30 NOMAC-E2 / n=16 DRSP-EE) 3.04  (1.95) 4.34  (2.38)
Cycle 2, Day 2 (n=29 NOMAC-E2 / n=16 DRSP-EE) 3.47  (2.20) 4.81  (3.01)
Cycle 2, Day 5 (n=29 NOMAC-E2 / n=15 DRSP-EE) 3.04  (1.94) 5.08  (3.21)
Cycle 2, Day 8 (n=29 NOMAC-E2 / n=16 DRSP-EE) 2.48  (1.85) 3.33  (1.97)
Cycle 2, Day 11 (n=29 NOMAC-E2 / n=16 DRSP-EE) 2.54  (2.01) 2.70  (2.18)
Cycle 2, Day 14 (n=29 NOMAC-E2 / n=15 DRSP-EE) 2.39  (2.17) 1.69  (1.42)
Cycle 2, Day 18 (n=28 NOMAC-E2 / n=15 DRSP-EE) 2.05  (1.76) 1.60  (1.31)
Cycle 2, Day 21 (n=27 NOMAC-E2 / n=16 DRSP-EE) 1.68  (1.44) 0.97  (0.67)
Cycle 2, Day 24 (n=27 NOMAC-E2 / n=16 DRSP-EE) 1.81  (1.75) 2.38  (2.01)
Cycle 2, Day 27 (n=27 NOMAC-E2 / n=16 DRSP-EE) 3.37  (2.90) 3.92  (2.17)
Cycle 3, Day 2 (n=27 NOMAC-E2 / n=14 DRSP-EE) 3.71  (2.23) 4.79  (2.67)
Cycle 6, Day 14 (n=25 NOMAC-E2 / n=14 DRSP-EE) 2.29  (1.86) 2.15  (2.83)
Cycle 6, Day 18 (n=26 NOMAC-E2 / n=15 DRSP-EE) 1.88  (2.05) 1.27  (1.02)
Cycle 6, Day 21 (n=26 NOMAC-E2 / n=15 DRSP-EE) 2.00  (1.68) 1.14  (0.89)
Cycle 6, Day 24 (n=26 NOMAC-E2 / n=14 DRSP-EE) 1.85  (1.75) 2.56  (2.12)
Cycle 6, Day 27 (n=26 NOMAC-E2 / n=15 DRSP-EE) 3.13  (2.21) 4.03  (2.57)
7.Secondary Outcome
Title Effect on Cervical Mucus as Determined by Insler Score
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description

ITT group consisted of all participants who were treated.

n=number of participants with non-missing values at the respective time point.

Arm/Group Title NOMAC-E2 DRSP-EE
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 32 16
Mean (Standard Deviation)
Unit of Measure: score on a scale
Screening cycle (n=32 NOMAC-E2 / n=16 DRSP-EE) 8.9  (2.55) 7.3  (3.61)
Cycle 1 (n=30 NOMAC-E2 / n=15 DRSP-EE) 2.3  (1.93) 3.2  (2.43)
Cycle 2 (n=0 NOMAC-E2 / n=2 DRSP-EE) NA [1]   (NA) 4.5  (0.71)
Cycle 7 (n=22 NOMAC-E2 / n=15 DRSP-EE) 7.0  (2.94) 8.7  (1.53)
[1]
Mean and standard deviation do not apply for zero participants.
8.Secondary Outcome
Title Effect on Maximum Endometrial Thickness
Hide Description Maximum endometrial thickness was defined as the largest endometrial thickness during a cycle.
Time Frame Screening Cycle, Cycle 1, Cycle 2, and Cycle 6
Hide Outcome Measure Data
Hide Analysis Population Description

ITT group consisted of all participants who were treated.

n=number of participants completing the respective cycle.

Arm/Group Title NOMAC-E2 DRSP-EE
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 32 16
Mean (Standard Deviation)
Unit of Measure: mm
Screening cycle (n=32 NOMAC-E2 / n=16 DRSP-EE) 9.9  (1.91) 10.1  (2.50)
Cycle 1 (n=32 NOMAC-E2 / n=16 DRSP-EE) 5.9  (1.22) 6.1  (1.25)
Cycle 2 (n=29 NOMAC-E2 / n=16 DRSP-EE) 5.3  (0.71) 6.8  (1.73)
Cycle 6 (n=26 NOMAC-E2 / n=15 DRSP-EE) 4.9  (0.66) 5.5  (1.30)
9.Secondary Outcome
Title Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title NOMAC-E2 DRSP-EE
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 24 12
Overall Number of Units Analyzed
Type of Units Analyzed: Woman years (rounded to nearest integer)
8 5
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Pregnancies per 100 woman years
0
(0 to 45.9)
0
(0 to 72.7)
10.Secondary Outcome
Title Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description

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/Group Title NOMAC-E2 DRSP-EE
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 30 16
Measure Type: Number
Unit of Measure: Participants
Cycle 1 (n=30 NOMAC-E2 / n=16 DRSP-EE) 7 1
Cycle 2 (n=27 NOMAC-E2 / n=16 DRSP-EE) 6 0
Cycle 3 (n=26 NOMAC-E2 / n=15 DRSP-EE) 5 0
Cycle 4 (n=26 NOMAC-E2 / n=15 DRSP-EE) 5 0
Cycle 5 (n=26 NOMAC-E2 / n=15 DRSP-EE) 8 0
Cycle 6 (n=26 NOMAC-E2 / n=14 DRSP-EE) 5 0
11.Secondary Outcome
Title Number of Participants With an Occurrence of Absence of Withdrawal Bleeding
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description

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/Group Title NOMAC-E2 DRSP-EE
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 30 16
Measure Type: Number
Unit of Measure: Participants
Cycle 1 (n=30 NOMAC-E2 / n=16 DRSP-EE) 3 0
Cycle 2 (n=27 NOMAC-E2 / n=16 DRSP-EE) 2 0
Cycle 3 (n=26 NOMAC-E2 / n=15 DRSP-EE) 2 0
Cycle 4 (n=26 NOMAC-E2 / n=15 DRSP-EE) 2 0
Cycle 5 (n=26 NOMAC-E2 / n=15 DRSP-EE) 2 0
Cycle 6 (n=26 NOMAC-E2 / n=14 DRSP-EE) 4 1
12.Secondary Outcome
Title Number of Participants With an Occurrence of Breakthrough Bleeding
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description

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/Group Title NOMAC-E2 DRSP-EE
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 30 16
Measure Type: Number
Unit of Measure: Participants
Cycle 1 (n=30 NOMAC-E2 / n=16 DRSP-EE) 0 0
Cycle 2 (n=27 NOMAC-E2 / n=16 DRSP-EE) 0 0
Cycle 3 (n=26 NOMAC-E2 / n=15 DRSP-EE) 0 0
Cycle 4 (n=26 NOMAC-E2 / n=15 DRSP-EE) 1 0
Cycle 5 (n=26 NOMAC-E2 / n=15 DRSP-EE) 1 0
Cycle 6 (n=26 NOMAC-E2 / n=14 DRSP-EE) 0 0
13.Secondary Outcome
Title Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description

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/Group Title NOMAC-E2 DRSP-EE
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 30 16
Measure Type: Number
Unit of Measure: Participants
Cycle 1 (n=30 NOMAC-E2 / n=16 DRSP-EE) 7 1
Cycle 2 (n=27 NOMAC-E2 / n=16 DRSP-EE) 6 0
Cycle 3 (n=26 NOMAC-E2 / n=15 DRSP-EE) 5 0
Cycle 4 (n=26 NOMAC-E2 / n=15 DRSP-EE) 4 0
Cycle 5 (n=26 NOMAC-E2 / n=15 DRSP-EE) 7 0
Cycle 6 (n=26 NOMAC-E2 / n=14 DRSP-EE) 5 0
14.Secondary Outcome
Title Number of Participants With an Occurrence of Early Withdrawal Bleeding
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description

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/Group Title NOMAC-E2 DRSP-EE
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 30 16
Measure Type: Number
Unit of Measure: Participants
Cycle 1 (n=30 NOMAC-E2 / n=16 DRSP-EE) 4 2
Cycle 2 (n=27 NOMAC-E2 / n=16 DRSP-EE) 4 0
Cycle 3 (n=26 NOMAC-E2 / n=15 DRSP-EE) 1 0
Cycle 4 (n=26 NOMAC-E2 / n=15 DRSP-EE) 2 0
Cycle 5 (n=26 NOMAC-E2 / n=15 DRSP-EE) 1 0
Cycle 6 (n=26 NOMAC-E2 / n=14 DRSP-EE) 2 0
15.Secondary Outcome
Title Number of Participants With an Occurrence of Continued Withdrawal Bleeding
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title NOMAC-E2 DRSP-EE
Hide Arm/Group Description:

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.

n=number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined).

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.

n=number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined).

Overall Number of Participants Analyzed 30 16
Measure Type: Number
Unit of Measure: Participants
Cycle 1 (n=29 NOMAC-E2 / n=16 DRSP-EE) 11 12
Cycle 2 (n=27 NOMAC-E2 / n=16 DRSP-EE) 8 10
Cycle 3 (n=25 NOMAC-E2 / n=15 DRSP-EE) 8 11
Cycle 4 (n=26 NOMAC-E2 / n=15 DRSP-EE) 12 12
Cycle 5 (n=26 NOMAC-E2 / n=14 DRSP-EE) 9 10
16.Secondary Outcome
Title Average Number of Breakthrough Bleeding/Spotting Days
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description

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/Group Title NOMAC-E2 DRSP-EE
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 30 16
Mean (Standard Deviation)
Unit of Measure: Days
Cycle 1 (n=7 NOMAC-E2; n=1 DRSP-EE) 3.0  (2.2) 2.0 [1]   (NA)
Cycle 2 (n=6 NOMAC-E2; n=0 DRSP-EE) 2.7  (1.9) NA [2]   (NA)
Cycle 3 (n=5 NOMAC-E2; n=0 DRSP-EE) 2.2  (1.1) NA [2]   (NA)
Cycle 4 (n=5 NOMAC-E2; n=0 DRSP-EE) 4.0  (2.8) NA [2]   (NA)
Cycle 5 (n=8 NOMAC-E2; n=0 DRSP-EE) 3.5  (2.3) NA [2]   (NA)
Cycle 6 (n=5 NOMAC-E2; n=0 DRSP-EE) 3.6  (2.1) NA [2]   (NA)
[1]
Value for one participant; therefore, standard deviation does not apply.
[2]
Mean and standard deviation do not apply for zero participants.
17.Secondary Outcome
Title Average Number of Withdrawal Bleeding Days
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description

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/Group Title NOMAC-E2 DRSP-EE
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 30 16
Mean (Standard Deviation)
Unit of Measure: Days
Cycle 1 (n=27 NOMAC-E2; n=16 DRSP-EE) 7.2  (6.7) 7.0  (4.7)
Cycle 1 (n=25 NOMAC-E2; n=16 DRSP-EE) 7.4  (7.5) 5.0  (1.7)
Cycle 3 (n=24 NOMAC-E2; n=15 DRSP-EE) 4.3  (2.4) 5.4  (1.5)
Cycle 4 (n=24 NOMAC-E2; n=15 DRSP-EE) 4.7  (1.9) 5.3  (1.0)
Cycle 5 (n=24 NOMAC-E2; n=15 DRSP-EE) 5.5  (6.1) 4.9  (1.1)
Cycle 6 (n=22 NOMAC-E2; n=13 DRSP-EE) 5.2  (6.3) 3.9  (0.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title NOMAC-E2 DRSP-EE
Hide Arm/Group Description 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. 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.
All-Cause Mortality
NOMAC-E2 DRSP-EE
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
NOMAC-E2 DRSP-EE
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/32 (3.13%)      0/16 (0.00%)    
Gastrointestinal disorders     
Appendicitis perforated  1/32 (3.13%)  1 0/16 (0.00%)  0
1
Term from vocabulary, MedDRA (10.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
NOMAC-E2 DRSP-EE
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/32 (93.75%)      15/16 (93.75%)    
Cardiac disorders     
Palpitations  2/32 (6.25%)  2 0/16 (0.00%)  0
Eye disorders     
Conjunctivitis  0/32 (0.00%)  0 2/16 (12.50%)  2
Gastrointestinal disorders     
Abdominal distension  3/32 (9.38%)  3 0/16 (0.00%)  0
Abdominal pain  3/32 (9.38%)  3 0/16 (0.00%)  0
Abdominal pain lower  5/32 (15.63%)  6 3/16 (18.75%)  4
Constipation  0/32 (0.00%)  0 1/16 (6.25%)  1
Diarrhoea  11/32 (34.38%)  13 0/16 (0.00%)  0
Food poisoning  0/32 (0.00%)  0 1/16 (6.25%)  1
Nausea  8/32 (25.00%)  11 3/16 (18.75%)  5
Toothache  3/32 (9.38%)  4 1/16 (6.25%)  1
Vomiting  2/32 (6.25%)  2 4/16 (25.00%)  5
General disorders     
Fatigue  2/32 (6.25%)  2 1/16 (6.25%)  1
Hangover  5/32 (15.63%)  7 1/16 (6.25%)  1
Malaise  3/32 (9.38%)  3 1/16 (6.25%)  1
Immune system disorders     
Hypersensitivity  0/32 (0.00%)  0 1/16 (6.25%)  1
Infections and infestations     
Cystitis  4/32 (12.50%)  8 3/16 (18.75%)  4
Gastroenteritis  3/32 (9.38%)  3 0/16 (0.00%)  0
Influenza  5/32 (15.63%)  7 7/16 (43.75%)  7
Nasopharyngitis  15/32 (46.88%)  23 9/16 (56.25%)  12
Pyelonephritis  0/32 (0.00%)  0 1/16 (6.25%)  1
Vaginal candidiasis  2/32 (6.25%)  2 1/16 (6.25%)  1
Injury, poisoning and procedural complications     
Foreign body in eye  0/32 (0.00%)  0 1/16 (6.25%)  1
Procedural pain  3/32 (9.38%)  3 0/16 (0.00%)  0
Sunburn  0/32 (0.00%)  0 1/16 (6.25%)  1
Investigations     
Weight decreased  2/32 (6.25%)  2 0/16 (0.00%)  0
Weight increased  4/32 (12.50%)  4 1/16 (6.25%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  2/32 (6.25%)  3 1/16 (6.25%)  1
Back pain  5/32 (15.63%)  8 1/16 (6.25%)  2
Nervous system disorders     
Dizziness  3/32 (9.38%)  4 0/16 (0.00%)  0
Headache  8/32 (25.00%)  17 4/16 (25.00%)  7
Psychiatric disorders     
Affect lability  4/32 (12.50%)  4 1/16 (6.25%)  1
Depressed mood  3/32 (9.38%)  3 0/16 (0.00%)  0
Renal and urinary disorders     
Dysuria  0/32 (0.00%)  0 1/16 (6.25%)  1
Micturition urgency  1/32 (3.13%)  1 1/16 (6.25%)  1
Reproductive system and breast disorders     
Breast enlargement  1/32 (3.13%)  1 3/16 (18.75%)  3
Breast pain  0/32 (0.00%)  0 4/16 (25.00%)  7
Breast tenderness  2/32 (6.25%)  2 0/16 (0.00%)  0
Dysmenorrhoea  2/32 (6.25%)  2 1/16 (6.25%)  1
Pelvic pain  3/32 (9.38%)  4 2/16 (12.50%)  2
Vaginal discharge  2/32 (6.25%)  2 1/16 (6.25%)  3
Vaginal odour  0/32 (0.00%)  0 2/16 (12.50%)  2
Respiratory, thoracic and mediastinal disorders     
Pharyngolaryngeal pain  4/32 (12.50%)  5 1/16 (6.25%)  1
Skin and subcutaneous tissue disorders     
Acne  6/32 (18.75%)  6 1/16 (6.25%)  1
Dry skin  2/32 (6.25%)  2 0/16 (0.00%)  0
Eczema  0/32 (0.00%)  0 1/16 (6.25%)  2
Hirsutism  0/32 (0.00%)  0 1/16 (6.25%)  1
Pain of skin  0/32 (0.00%)  0 1/16 (6.25%)  2
Skin odour abnormal  0/32 (0.00%)  0 1/16 (6.25%)  1
Vascular disorders     
Hot flush  2/32 (6.25%)  2 0/16 (0.00%)  0
1
Term from vocabulary, MedDRA (10.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00511433     History of Changes
Other Study ID Numbers: P05723
Organon protocol 292003
First Submitted: August 2, 2007
First Posted: August 3, 2007
Results First Submitted: July 28, 2011
Results First Posted: August 29, 2011
Last Update Posted: November 26, 2014