Trial Outcomes & Findings for Contraceptive Efficacy and Safety of NOMAC-E2 Combined Oral Contraceptive (NCT NCT05264506)
NCT ID: NCT05264506
Last Updated: 2025-11-21
Results Overview
Raw count of the number of pregnancies that occurred while participants were taking study drug
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
3055 participants
Primary outcome timeframe
1 year
Results posted on
2025-11-21
Participant Flow
A total of 3,055 participants were screened for the study. Out of these 1,135 participants failed the screening process. One participant was found pregnant before starting treatment, however not identified as a screen failure
Participant milestones
| Measure |
Nomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
The NOMAC-E2 COC active tablets contain 2.5 mg NOMAC and 1.5 mg E2 and will be used in a 24/4 regimen, i.e., 28-day cycles with 24 days of active tablet intake followed by 4 days of placebo tablet intake.
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|---|---|
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Overall Study
STARTED
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1919
|
|
Overall Study
COMPLETED
|
402
|
|
Overall Study
NOT COMPLETED
|
1517
|
Reasons for withdrawal
| Measure |
Nomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
The NOMAC-E2 COC active tablets contain 2.5 mg NOMAC and 1.5 mg E2 and will be used in a 24/4 regimen, i.e., 28-day cycles with 24 days of active tablet intake followed by 4 days of placebo tablet intake.
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|---|---|
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Overall Study
Adverse Event
|
59
|
|
Overall Study
Lost to Follow-up
|
204
|
|
Overall Study
Protocol Violation
|
185
|
|
Overall Study
Pregnancy
|
60
|
|
Overall Study
Physician Decision
|
6
|
|
Overall Study
Non-compliance with Study Drug
|
29
|
|
Overall Study
Study termination
|
677
|
|
Overall Study
Withdrawal by Subject
|
208
|
|
Overall Study
Discontinued prior treatment
|
89
|
Baseline Characteristics
Contraceptive Efficacy and Safety of NOMAC-E2 Combined Oral Contraceptive
Baseline characteristics by cohort
| Measure |
Nomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
n=1830 Participants
The NOMAC-E2 COC active tablets contain 2.5 mg NOMAC and 1.5 mg E2 and will be used in a 24/4 regimen, i.e., 28-day cycles with 24 days of active tablet intake followed by 4 days of placebo tablet intake.
NOMAC-E2 COC: Dosage Formulation: Film-coated Tablet Unit Dose Strength: Nomegestrol acetate (NOMAC) 2.5 mg and estradiol (E2) 1.5 mg; Each blister strip contains 28 tablets: 24 tablets with the active drug (number 1 to 24) and 4 tablets with placebo (number 25 to 28).
Dosing Instructions: oral. Take 1 tablet daily at about the same time as directed.
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|---|---|
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Age, Continuous
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27.2 years
STANDARD_DEVIATION 4.99 • n=39 Participants
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Sex: Female, Male
Female
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1830 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1004 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
817 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
15 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
29 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
6 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
356 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
1358 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
34 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
32 Participants
n=39 Participants
|
|
Region of Enrollment
United States
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1830 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: All Participants as Treated Population, which consisted of all participants who took at least one dose of trial medication.
Raw count of the number of pregnancies that occurred while participants were taking study drug
Outcome measures
| Measure |
Nomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
n=1830 Participants
The NOMAC-E2 COC active tablets contain 2.5 mg NOMAC and 1.5 mg E2 and will be used in a 24/4 regimen, i.e., 28-day cycles with 24 days of active tablet intake followed by 4 days of placebo tablet intake.
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|---|---|
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Number of Participants With On-treatment Pregnancies
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57 Participants
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SECONDARY outcome
Timeframe: 1 yearPopulation: All Participants as Treated Population, which consisted of all participants who took at least one dose of trial medication.
Outcome measures
| Measure |
Nomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
n=1830 Participants
The NOMAC-E2 COC active tablets contain 2.5 mg NOMAC and 1.5 mg E2 and will be used in a 24/4 regimen, i.e., 28-day cycles with 24 days of active tablet intake followed by 4 days of placebo tablet intake.
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|---|---|
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Proportion of Participants With an Adverse Event (Regardless on Potential Relationship to Study Drug)
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485 participants
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SECONDARY outcome
Timeframe: 1 yearPopulation: All Participants as Treated Population, which consisted of all randomized participants who took at least one dose of trial medication.
Outcome measures
| Measure |
Nomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
n=1830 Participants
The NOMAC-E2 COC active tablets contain 2.5 mg NOMAC and 1.5 mg E2 and will be used in a 24/4 regimen, i.e., 28-day cycles with 24 days of active tablet intake followed by 4 days of placebo tablet intake.
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|---|---|
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Proportion of Participants Who Prematurely Discontinue Study Drug Treatment
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62 participants
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SECONDARY outcome
Timeframe: 1 yearPopulation: Participants with at least one completed cycle
Number of participants with on-treatment pregnancies as a percentage of the number of participants with at least one completed cycle
Outcome measures
| Measure |
Nomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
n=1756 Participants
The NOMAC-E2 COC active tablets contain 2.5 mg NOMAC and 1.5 mg E2 and will be used in a 24/4 regimen, i.e., 28-day cycles with 24 days of active tablet intake followed by 4 days of placebo tablet intake.
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|---|---|
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Percentage of Participants With On-treatment Pregnancies With at Least One Completed Cycle
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3.1 percentage of participants
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SECONDARY outcome
Timeframe: 1 yearPopulation: Participants with a known date of conception
In participants who experienced on-treatment pregnancy, the mean number of completed treatment cycles prior to occurrence of the pregnancy (for participants with known date of conception)
Outcome measures
| Measure |
Nomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
n=31 Participants
The NOMAC-E2 COC active tablets contain 2.5 mg NOMAC and 1.5 mg E2 and will be used in a 24/4 regimen, i.e., 28-day cycles with 24 days of active tablet intake followed by 4 days of placebo tablet intake.
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|---|---|
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Number of Cycles of Exposure Prior to Pregnancy
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4.2 completed cycles
Standard Deviation 3.47
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SECONDARY outcome
Timeframe: 1 yearRaw count of the number of pregnancies that occurred while participants were taking study drug in each BMI category
Outcome measures
| Measure |
Nomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
n=57 Participants
The NOMAC-E2 COC active tablets contain 2.5 mg NOMAC and 1.5 mg E2 and will be used in a 24/4 regimen, i.e., 28-day cycles with 24 days of active tablet intake followed by 4 days of placebo tablet intake.
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|---|---|
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Number of Participants With a Pregnancy, Based on Baseline BMI Categories (<30 kg/m2, ≥30 kg/m2)
BMI <30 kg/m2
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39 Participants
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Number of Participants With a Pregnancy, Based on Baseline BMI Categories (<30 kg/m2, ≥30 kg/m2)
BMI >=30 kg/m2
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18 Participants
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SECONDARY outcome
Timeframe: 28-day cycles across one yearPopulation: Participants with at least one completed cycle
Number of participants with bleeding-spotting days as a proportion of the number of participants who had at least one completed cycle
Outcome measures
| Measure |
Nomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
n=1756 Participants
The NOMAC-E2 COC active tablets contain 2.5 mg NOMAC and 1.5 mg E2 and will be used in a 24/4 regimen, i.e., 28-day cycles with 24 days of active tablet intake followed by 4 days of placebo tablet intake.
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|---|---|
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Proportion of Participants With Bleeding-spotting Days
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1721 participants
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SECONDARY outcome
Timeframe: 28-day cycles across one yearPopulation: Participants with at least one completed cycle
For participants who had at least one completed cycle, the mean number of bleeding-spotting days per cycle
Outcome measures
| Measure |
Nomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
n=1756 Participants
The NOMAC-E2 COC active tablets contain 2.5 mg NOMAC and 1.5 mg E2 and will be used in a 24/4 regimen, i.e., 28-day cycles with 24 days of active tablet intake followed by 4 days of placebo tablet intake.
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|---|---|
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Mean Number of Bleeding and/or Spotting Days Per Cycle
|
4.0 bleeding-spotting days
Standard Deviation 3.44
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SECONDARY outcome
Timeframe: 91-day reference periods across one yearPopulation: Participants with at least one completed reference period
For participants with at least one completed reference period, the average number of bleeding-spotting days per reference period
Outcome measures
| Measure |
Nomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
n=1518 Participants
The NOMAC-E2 COC active tablets contain 2.5 mg NOMAC and 1.5 mg E2 and will be used in a 24/4 regimen, i.e., 28-day cycles with 24 days of active tablet intake followed by 4 days of placebo tablet intake.
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|---|---|
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Average Number of Bleeding-spotting Days Per Reference Period
|
13.1 bleeding-spotting days
Standard Deviation 8.54
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SECONDARY outcome
Timeframe: 28-day cycles across one yearPopulation: Participants with at least one completed cycle
Proportion of participants who had at least one completed cycle with 8 or more bleeding-spotting days in a cycle
Outcome measures
| Measure |
Nomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
n=1756 Participants
The NOMAC-E2 COC active tablets contain 2.5 mg NOMAC and 1.5 mg E2 and will be used in a 24/4 regimen, i.e., 28-day cycles with 24 days of active tablet intake followed by 4 days of placebo tablet intake.
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|---|---|
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Proportion of Participants With 8 or More Bleeding-spotting Days
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709 participants
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SECONDARY outcome
Timeframe: Treatment Week 5Population: PK participants who completed Visit 3 pre-dose sampling
NOMAC concentrations assessed through use of sparse sampling
Outcome measures
| Measure |
Nomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
n=222 Participants
The NOMAC-E2 COC active tablets contain 2.5 mg NOMAC and 1.5 mg E2 and will be used in a 24/4 regimen, i.e., 28-day cycles with 24 days of active tablet intake followed by 4 days of placebo tablet intake.
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|---|---|
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Mean NOMAC Concentration, Visit 3 Pre-Dose
|
32.26 ng/mL
Standard Deviation 310.457
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SECONDARY outcome
Timeframe: Treatment Week 5Population: PK participants who completed Visit 3 post-dose sampling
NOMAC concentrations assessed through use of sparse sampling
Outcome measures
| Measure |
Nomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
n=223 Participants
The NOMAC-E2 COC active tablets contain 2.5 mg NOMAC and 1.5 mg E2 and will be used in a 24/4 regimen, i.e., 28-day cycles with 24 days of active tablet intake followed by 4 days of placebo tablet intake.
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|---|---|
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Mean NOMAC Concentration, Visit 3 Post-Dose
|
73.61 ng/mL
Standard Deviation 742.410
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SECONDARY outcome
Timeframe: Treatment Week 17Population: PK participants who completed Visit 4 pre-dose sampling
NOMAC concentrations assessed through use of sparse sampling
Outcome measures
| Measure |
Nomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
n=161 Participants
The NOMAC-E2 COC active tablets contain 2.5 mg NOMAC and 1.5 mg E2 and will be used in a 24/4 regimen, i.e., 28-day cycles with 24 days of active tablet intake followed by 4 days of placebo tablet intake.
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|---|---|
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Mean NOMAC Concentration, Visit 4 Pre-Dose
|
36.01 ng/mL
Standard Deviation 229.607
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SECONDARY outcome
Timeframe: Treatment Week 17Population: PK participants who completed Visit 4 post-dose sampling
NOMAC concentrations assessed through use of sparse sampling
Outcome measures
| Measure |
Nomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
n=164 Participants
The NOMAC-E2 COC active tablets contain 2.5 mg NOMAC and 1.5 mg E2 and will be used in a 24/4 regimen, i.e., 28-day cycles with 24 days of active tablet intake followed by 4 days of placebo tablet intake.
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|---|---|
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Mean NOMAC Concentration, Visit 4 Post-Dose
|
58.01 ng/mL
Standard Deviation 363.400
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Adverse Events
Nomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
Serious events: 10 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
n=1830 participants at risk
The NOMAC-E2 COC active tablets contain 2.5 mg NOMAC and 1.5 mg E2 and will be used in a 24/4 regimen, i.e., 28-day cycles with 24 days of active tablet intake followed by 4 days of placebo tablet intake.
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|---|---|
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Injury, poisoning and procedural complications
Burns third degree
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0.05%
1/1830 • Number of events 1 • All AEs and SAEs were collected from the time of screening through the end of study/end of treatment visit, which was 14 to 19 days after the last intake of study drug, up to approximately 1 year, 1 month.
The Safety Analysis Set consists of all participants who took at least one dose of the study treatment.
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|
Injury, poisoning and procedural complications
Ligament rupture
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0.05%
1/1830 • Number of events 1 • All AEs and SAEs were collected from the time of screening through the end of study/end of treatment visit, which was 14 to 19 days after the last intake of study drug, up to approximately 1 year, 1 month.
The Safety Analysis Set consists of all participants who took at least one dose of the study treatment.
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Nervous system disorders
Headache
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0.05%
1/1830 • Number of events 1 • All AEs and SAEs were collected from the time of screening through the end of study/end of treatment visit, which was 14 to 19 days after the last intake of study drug, up to approximately 1 year, 1 month.
The Safety Analysis Set consists of all participants who took at least one dose of the study treatment.
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|
Nervous system disorders
Paraesthesia
|
0.05%
1/1830 • Number of events 1 • All AEs and SAEs were collected from the time of screening through the end of study/end of treatment visit, which was 14 to 19 days after the last intake of study drug, up to approximately 1 year, 1 month.
The Safety Analysis Set consists of all participants who took at least one dose of the study treatment.
|
|
Psychiatric disorders
Suicidal ideation
|
0.11%
2/1830 • Number of events 2 • All AEs and SAEs were collected from the time of screening through the end of study/end of treatment visit, which was 14 to 19 days after the last intake of study drug, up to approximately 1 year, 1 month.
The Safety Analysis Set consists of all participants who took at least one dose of the study treatment.
|
|
Psychiatric disorders
Bipolar disorder
|
0.05%
1/1830 • Number of events 1 • All AEs and SAEs were collected from the time of screening through the end of study/end of treatment visit, which was 14 to 19 days after the last intake of study drug, up to approximately 1 year, 1 month.
The Safety Analysis Set consists of all participants who took at least one dose of the study treatment.
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.05%
1/1830 • Number of events 1 • All AEs and SAEs were collected from the time of screening through the end of study/end of treatment visit, which was 14 to 19 days after the last intake of study drug, up to approximately 1 year, 1 month.
The Safety Analysis Set consists of all participants who took at least one dose of the study treatment.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.05%
1/1830 • Number of events 1 • All AEs and SAEs were collected from the time of screening through the end of study/end of treatment visit, which was 14 to 19 days after the last intake of study drug, up to approximately 1 year, 1 month.
The Safety Analysis Set consists of all participants who took at least one dose of the study treatment.
|
|
Vascular disorders
Hypertension
|
0.05%
1/1830 • Number of events 1 • All AEs and SAEs were collected from the time of screening through the end of study/end of treatment visit, which was 14 to 19 days after the last intake of study drug, up to approximately 1 year, 1 month.
The Safety Analysis Set consists of all participants who took at least one dose of the study treatment.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.16%
3/1830 • Number of events 3 • All AEs and SAEs were collected from the time of screening through the end of study/end of treatment visit, which was 14 to 19 days after the last intake of study drug, up to approximately 1 year, 1 month.
The Safety Analysis Set consists of all participants who took at least one dose of the study treatment.
|
Other adverse events
Adverse event data not reported
Additional Information
Clinical Lead, Late-Stage Clinical Development
Organon and Co
Phone: 551-430-6000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place