> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/contraceptive-efficacy-and-safety-of-nomac-e2-combined-oral-3608af25-8fcd-490b-b7a8-24ba26e103ca > Record changed: 2026-10-13 # Contraceptive Efficacy and Safety of NOMAC-E2 Combined Oral Contraceptive NCT05264506 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05264506) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05264506) Recruitment status Terminated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05264506) Participants 3,055 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05264506) Lead sponsor Organon and Co Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05264506) Start date 2022-02-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05264506) Number of sites 103 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05264506) ## Title and summary **Summary** The purpose of this study is evaluating Contraceptive Efficacy and Safety of NOMAC-E2 Combined Oral Contraceptive in Premenopausal Females Aged 14 to 35 Years (Inclusive). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05264506) **Short title** Contraceptive Efficacy and Safety of NOMAC-E2 Combined Oral Contraceptive Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05264506) **Official title** A Phase 3, Open-label, Multi-center, Single-arm Study to Assess Contraceptive Efficacy and Safety of the Nomegestrol Acetate + 17β-estradiol Combined Oral Contraceptive (OG-8175A) in Premenopausal Females Aged 14 to 35 Years (Inclusive) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05264506) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05264506) **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05264506) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05264506) **Recruitment status** Terminated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05264506) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05264506) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05264506) **Reason stopped** Sponsor decision to stop the study early and complete all required study close-out activities. This decision was made for business reasons unrelated to safety. None of the pre-specified efficacy endpoints were analyzed. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05264506) ## Dates **Completion date** 2024-01-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05264506) **First posted** 2022-03-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05264506) **Registry last updated** 2025-11-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05264506) **Primary completion date** 2024-01-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05264506) **Start date** 2022-02-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05264506) ## Size and sites **Actual participants** 3,055 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05264506) **Participants** 3,055 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05264506) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05264506) **Protocol amendments** 9 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05264506) **Number of sites** 103 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05264506) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05264506) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05264506) **Lead sponsor** Organon and Co Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05264506) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05264506) ## Identifiers **Registry ID** NCT05264506 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05264506) **ClinicalTrials.gov ID** NCT05264506 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05264506) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05264506) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Prevention **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05264506) ## Outcomes ### Primary outcomes 1. Number of Participants With On-treatment Pregnancies Timeframe: 1 year Raw count of the number of pregnancies that occurred while participants were taking study drug ### Secondary outcomes 1. Proportion of Participants With an Adverse Event (Regardless on Potential Relationship to Study Drug) Timeframe: 1 year 2. Proportion of Participants Who Prematurely Discontinue Study Drug Treatment Timeframe: 1 year 3. Percentage of Participants With On-treatment Pregnancies With at Least One Completed Cycle Timeframe: 1 year Number of participants with on-treatment pregnancies as a percentage of the number of participants with at least one completed cycle 4. Number of Cycles of Exposure Prior to Pregnancy Timeframe: 1 year 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) 5. Number of Participants With a Pregnancy, Based on Baseline BMI Categories (<30 kg/m2, ≥30 kg/m2) Timeframe: 1 year Raw count of the number of pregnancies that occurred while participants were taking study drug in each BMI category 6. Proportion of Participants With Bleeding-spotting Days Timeframe: 28-day cycles across one year Number of participants with bleeding-spotting days as a proportion of the number of participants who had at least one completed cycle 7. Mean Number of Bleeding and/or Spotting Days Per Cycle Timeframe: 28-day cycles across one year For participants who had at least one completed cycle, the mean number of bleeding-spotting days per cycle 8. Average Number of Bleeding-spotting Days Per Reference Period Timeframe: 91-day reference periods across one year For participants with at least one completed reference period, the average number of bleeding-spotting days per reference period 9. Proportion of Participants With 8 or More Bleeding-spotting Days Timeframe: 28-day cycles across one year Proportion of participants who had at least one completed cycle with 8 or more bleeding-spotting days in a cycle 10. Mean NOMAC Concentration, Visit 3 Pre-Dose Timeframe: Treatment Week 5 NOMAC concentrations assessed through use of sparse sampling 11. Mean NOMAC Concentration, Visit 3 Post-Dose Timeframe: Treatment Week 5 NOMAC concentrations assessed through use of sparse sampling 12. Mean NOMAC Concentration, Visit 4 Pre-Dose Timeframe: Treatment Week 17 NOMAC concentrations assessed through use of sparse sampling 13. Mean NOMAC Concentration, Visit 4 Post-Dose Timeframe: Treatment Week 17 NOMAC concentrations assessed through use of sparse sampling Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05264506) ## Eligibility **Sex** Female **Age groups** Children, Adults **Minimum age** 14 Years **Maximum age** 35 Years **Healthy volunteers** No ### Inclusion criteria - Postmenarcheal, premenopausal female aged 14 to 35 years (inclusive) - At risk for pregnancy (including heterosexual vaginal intercourse at least once a month and not sterilized). - No desire for pregnancy within 1 year following screening and is not intending to use any other form of contraception - Good physical and mental health - History of regular menstrual cycles prior to the use of any hormonal contraceptive. - Able and willing to adhere study procedures ### Exclusion criteria - Current known or expected pregnancy - History of subfertility or infertility - Less than 2 normal menstrual cycles following recent pregnancy of gestational age - Breastfeeding within 2 months of study drug start - Known HIV infection - Untreated gonorrhea, chlamydia, or trichomonas - abnormal PAP within timeline of standard of care guidelines - Unexplained/unresolved abnormal vaginal bleeding - Presence/history of VTE, ATE, transient ischemic attack, angina pectoris, or claudication - Higher risk for VTE - Uncontrolled or severe hypertension - Severe dyslipoproteinemia - History of migraine with aura or focal neurological symptoms - Diabetes mellitus (with either end-organ involvement or >20 years duration) - Multiple cardiovascular risk factors - History of pancreatitis associated with severe hypertriglyceridemia - Presence/history of clinically significant liver disease - History of malabsorptive surgical procedures - History of malignancy in last 5 years - Presence/history of meningioma - Disease that may worsen under hormonal treatment - Presence/history of severe depression (unless currently stable and asymptomatic) - Known allergy/sensitivity to NOMAC-E2 - Drug or alcohol abuse/dependence in last 2 years - Clinically relevant abnormal lab result at screening - Expected use of other contraceptive medications or medications that induce liver enzymes during study - Used another investigational drug within 2 months of study drug start Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05264506) ## Sites - Alabama Clinical Therapeutics, LLCBirmingham, United States - SEC Clinical ResearchDothan, United States - Alliance for Multispecialty Research, LLCMobile, United States - Velocity Clinical ResearchMobile, United States - Mesa Obstetricians and GynecologistsMesa, United States - Desert Clinical Research, LLC/CCT ResearchMesa, United States - Velocity Clinical Research - PhoenixPhoenix, United States - Precision Trials AZ, LLCPhoenix, United States - Alliance for Multispecialty ResearchTempe, United States - Noble Clinical ResearchTucson, United States - Eclipse Clinical ResearchTucson, United States - Gardens Medical Center / Alliance Research InstituteBell Gardens, United States - Alliance Research Institute, LLCCanoga Park, United States - Advanced Investigative Medicine, IncHawthorne, United States - Marvel Clinical ResearchHuntington Beach, United States - Om Research LLCLancaster, United States - Empire Clinical ResearchPomona, United States - WR-Women's Health Care Research, LLCSan Diego, United States - WR-Medical Center For Clinical Research - San DiegoSan Diego, United States - Velocity Clinical ResearchDenver, United States - Physicians' Research Options / Red Rocks OB/GYNLakewood, United States - CMR of Greater New Haven, LLCHamden, United States - Alliance for Multispecialty Research, LLCCoral Gables, United States - Universal Axon Clinical Research, LLCDoral, United States - Alliance for Multispecialty Research, LLCFort Myers, United States And 78 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05264506) ## Related records ### Drugs (1) - [Nomegestrol acetate](https://trialight.com/data/asset/nomegestrol-acetate-2dc212bb-4e53-49f4-acd2-2f2cd1a6169a.md) ### Collaborators (1) - IQVIA Pty Ltd ### Lead sponsors (1) - [Organon and Co](https://trialight.com/data/company/organon-and-co-aef8c0c7-e814-4a91-a8fb-bb3b12559dfc.md) ### Targets (1) - [PGR](https://trialight.com/data/target/pgr-4e536b31-8799-5ace-a427-be36fd8a5f9f.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. 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