Contraceptive Efficacy and Safety of NOMAC-E2 Combined Oral Contraceptive

November 10, 2025 updated by: Organon and Co

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)

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is 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). Potential participants must be sexually active and engage in heterosexual vaginal intercourse at least once per month with a partner who is not known to be subfertile, sterilized, or infertile, and should not routinely use any other form of contraception.

A total of 2,680 fertile premenopausal women aged 14 to 35 years (inclusive) will be screened to achieve about 1,878 (with at least 657 participants with BMI ≥30 kg/m2) being allocated to study treatment. Over 1,000 total participants are expected to complete 1 year of treatment (13 cycles).

The total duration of study participation will be up to 60 weeks, which includes a Pre-treatment Period of approximately 6 weeks, a Treatment Period of 52 weeks, and a Follow-up Period of 2 weeks after the last intake of study drug.

Study Type

Interventional

Enrollment (Actual)

3055

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35235
        • Alabama Clinical Therapeutics, LLC
      • Dothan, Alabama, United States, 36305
        • Sec Clinical Research
      • Mobile, Alabama, United States, 36608
        • Alliance for Multispecialty Research, LLC
      • Mobile, Alabama, United States, 36608
        • Velocity Clinical Research
    • Arizona
      • Mesa, Arizona, United States, 85206
        • Mesa Obstetricians and Gynecologists
      • Mesa, Arizona, United States, 85213
        • Desert Clinical Research, LLC/CCT Research
      • Phoenix, Arizona, United States, 85032
        • Precision Trials AZ, LLC
      • Phoenix, Arizona, United States, 85006
        • Velocity Clinical Research - Phoenix
      • Tempe, Arizona, United States, 85281
        • Alliance for Multispecialty Research
      • Tucson, Arizona, United States, 85704
        • Noble Clinical Research
      • Tucson, Arizona, United States, 85745
        • Eclipse Clinical Research
    • California
      • Bell Gardens, California, United States, 90201
        • Gardens Medical Center / Alliance Research Institute
      • Canoga Park, California, United States, 91304
        • Alliance Research Institute, LLC
      • Hawthorne, California, United States, 90250
        • Advanced Investigative Medicine, Inc
      • Huntington Beach, California, United States, 92647
        • Marvel Clinical Research
      • Lancaster, California, United States, 93534
        • Om Research LLC
      • Pomona, California, United States, 91767
        • Empire Clinical Research
      • San Diego, California, United States, 92111
        • WR-Women's Health Care Research, LLC
      • San Diego, California, United States, 92120
        • WR-Medical Center For Clinical Research - San Diego
    • Colorado
      • Denver, Colorado, United States, 80209
        • Velocity Clinical Research
      • Lakewood, Colorado, United States, 80228
        • Physicians' Research Options / Red Rocks OB/GYN
    • Connecticut
      • Hamden, Connecticut, United States, 06517
        • CMR of Greater New Haven, LLC
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Alliance for Multispecialty Research, LLC
      • Doral, Florida, United States, 33166
        • Universal Axon Clinical Research, LLC
      • Fort Myers, Florida, United States, 33912
        • Alliance for Multispecialty Research, LLC
      • Lake Worth, Florida, United States, 33461
        • Altus Research, Inc.
      • Largo, Florida, United States, 33777
        • Accel Research Sites - St. Petersburg Clinical Research Unit
      • Leesburg, Florida, United States, 34748
        • Ob-Gyn Associates Of Mid-Florida, PA
      • Miami, Florida, United States, 33186
        • New Age Medical Research Corporation
      • Miami, Florida, United States, 33155
        • Miami Clinical Research
      • Miami, Florida, United States, 33176
        • Spotlight Research Center, LLC
      • Miami, Florida, United States, 33173
        • Genoma Research Group, Inc.
      • Miami, Florida, United States, 33173
        • AdMed Research, LLC
      • Miami, Florida, United States, 33155
        • Avantis Clinical Research, LLC
      • Miami Beach, Florida, United States, 33140
        • Quantum Clinical Trials
      • Miami Lakes, Florida, United States, 33016
        • Quality Research of South Florida
      • North Miami, Florida, United States, 33161
        • Healthcare Clinical Data, Inc.
      • Ocoee, Florida, United States, 34761
        • Sensible Healthcare LLC
      • Palmetto Bay, Florida, United States, 33157
        • Innovation Medical Research Center
      • Pompano Beach, Florida, United States, 33060
        • Clinical Research Center Of Florida
      • Tampa, Florida, United States, 33614
        • R & B Medical Center LLC
      • West Palm Beach, Florida, United States, 33409
        • Comprehensive Clinical Research, LLC
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Agile Clinical Research Trials, LLC
      • Morrow, Georgia, United States, 30260
        • Infinite Clinical Trials
      • Pooler, Georgia, United States, 31322
        • Javara Inc / Privia Medical Group Georgia, LLC
      • Sandy Springs, Georgia, United States, 30328
        • WR-Mount Vernon Clinical Research, LLC
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Women's Healthcare Associates P.A.
      • Idaho Falls, Idaho, United States, 83404
        • Leavitt Clinical Research
    • Iowa
      • Ankeny, Iowa, United States, 50023
        • The Iowa Clinic
    • Kansas
      • El Dorado, Kansas, United States, 67042
        • Alliance for Multispecialty Research, LLC
      • Newton, Kansas, United States, 67114
        • Alliance for Multispecialty Research, LLC
      • Wichita, Kansas, United States, 67207
        • Alliance for Multispecialty Research, LLC
      • Wichita, Kansas, United States, 67205
        • Alliance for Multispecialty Research, LLC
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Alliance for Multispecialty Research, LLC - Lexington
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Velocity Clinical Research - Covington
      • Lafayette, Louisiana, United States, 70508
        • Velocity Clinical Research
      • Metairie, Louisiana, United States, 70001
        • Southern Clinical Research Associates
      • Metairie, Louisiana, United States, 70006
        • Velocity Clinical Research
      • New Orleans, Louisiana, United States, 70119
        • Alliance for Multispecialty Research, LLC
      • Slidell, Louisiana, United States, 70458
        • Velocity Clinical Research
    • Maryland
      • Towson, Maryland, United States, 21204
        • Continental Clinical Solutions
    • Massachusetts
      • Fall River, Massachusetts, United States, 02721
        • NECCR PrimaCare Research, LLC
      • Fall River, Massachusetts, United States, 02723
        • Exordia Medical Research, Inc
    • Mississippi
      • Gulfport, Mississippi, United States, 39503
        • Velocity Clinical Research
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • Alliance for Multispecialty Research, LLC
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • Velocity Clinical Research
      • Hastings, Nebraska, United States, 68901
        • Velocity Clinical Research
      • Omaha, Nebraska, United States, 68134
        • Velocity Clinical Research
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Alliance for Multispecialty Research, LLC
      • Las Vegas, Nevada, United States, 89106
        • Jubilee Clinical Research, Inc
      • Las Vegas, Nevada, United States, 89113
        • Essential Women's Health Associates
    • New Jersey
      • Perth Amboy, New Jersey, United States, 08861
        • Planned Parenthood of Northern, Central, and Southern New Jersey
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Bosque Women's Care
      • Albuquerque, New Mexico, United States, 87102
        • Albuquerque Clinical Trials, Inc
    • New York
      • Vestal, New York, United States, 13850
        • Meridian Clinical Research, LLC
    • North Carolina
      • Durham, North Carolina, United States, 27713
        • Carolina Women's Research And Wellness Center
      • Fayetteville, North Carolina, United States, 28303
        • Carolina Institute for Clinical Research
      • Raleigh, North Carolina, United States, 27612
        • M3 Wake Research, Inc
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati Physicians
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16507
        • Ob/Gyn Associates Of Erie
      • Philadelphia, Pennsylvania, United States, 19114
        • Clinical Research Of Philadelphia, Llc
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Venus Gynecology, LLC
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Chattanooga Medical Research, LLC
      • Knoxville, Tennessee, United States, 37909
        • New Phase Research & Development
      • Knoxville, Tennessee, United States, 37909
        • Alliance for Multispecialty Research, LLC
      • Memphis, Tennessee, United States, 38120
        • WR-Medical Research Center of Memphis
    • Texas
      • Austin, Texas, United States, 78705
        • Tekton Research, Inc
      • Burleson, Texas, United States, 76028
        • Helios Clinical Research
      • Dallas, Texas, United States, 75251
        • Cedar Health Research
      • Fort Worth, Texas, United States, 76104
        • Helios Clinical Research
      • Houston, Texas, United States, 77074
        • Clinical Trial Network
      • Houston, Texas, United States, 77054
        • Javara Inc
      • Houston, Texas, United States, 77065
        • Accurate Clinical Research, Inc
      • Rowlett, Texas, United States, 75088
        • Texas Health Care, PLLC d/b/d Privia Medical Group - North Texas
      • San Antonio, Texas, United States, 78229
        • Tekton Research, Inc
      • Stephenville, Texas, United States, 76401
        • Javara Research
      • Sugar Land, Texas, United States, 77478
        • Javara Inc
      • Weatherford, Texas, United States, 76086
        • Helios Clinical Research - Weatherford
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Wasatch Clinical Research
    • Virginia
      • Forest, Virginia, United States, 24551
        • Javara Research
      • Norfolk, Virginia, United States, 23502
        • Alliance for Multispecialty Research, LLC
      • Norfolk, Virginia, United States, 23502
        • Tidewater Clinical Research
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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.

Other Names:
  • Nomegestrol acetate / estradiol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With On-treatment Pregnancies
Time Frame: 1 year
Raw count of the number of pregnancies that occurred while participants were taking study drug
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants With an Adverse Event (Regardless on Potential Relationship to Study Drug)
Time Frame: 1 year
1 year
Proportion of Participants Who Prematurely Discontinue Study Drug Treatment
Time Frame: 1 year
1 year
Percentage of Participants With On-treatment Pregnancies With at Least One Completed Cycle
Time Frame: 1 year
Number of participants with on-treatment pregnancies as a percentage of the number of participants with at least one completed cycle
1 year
Number of Cycles of Exposure Prior to Pregnancy
Time Frame: 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)
1 year
Number of Participants With a Pregnancy, Based on Baseline BMI Categories (<30 kg/m2, ≥30 kg/m2)
Time Frame: 1 year
Raw count of the number of pregnancies that occurred while participants were taking study drug in each BMI category
1 year
Proportion of Participants With Bleeding-spotting Days
Time Frame: 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
28-day cycles across one year
Mean Number of Bleeding and/or Spotting Days Per Cycle
Time Frame: 28-day cycles across one year
For participants who had at least one completed cycle, the mean number of bleeding-spotting days per cycle
28-day cycles across one year
Average Number of Bleeding-spotting Days Per Reference Period
Time Frame: 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
91-day reference periods across one year
Proportion of Participants With 8 or More Bleeding-spotting Days
Time Frame: 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
28-day cycles across one year
Mean NOMAC Concentration, Visit 3 Pre-Dose
Time Frame: Treatment Week 5
NOMAC concentrations assessed through use of sparse sampling
Treatment Week 5
Mean NOMAC Concentration, Visit 3 Post-Dose
Time Frame: Treatment Week 5
NOMAC concentrations assessed through use of sparse sampling
Treatment Week 5
Mean NOMAC Concentration, Visit 4 Pre-Dose
Time Frame: Treatment Week 17
NOMAC concentrations assessed through use of sparse sampling
Treatment Week 17
Mean NOMAC Concentration, Visit 4 Post-Dose
Time Frame: Treatment Week 17
NOMAC concentrations assessed through use of sparse sampling
Treatment Week 17

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Collaborators

IQVIA Pty Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2022

Primary Completion (Actual)

January 12, 2024

Study Completion (Actual)

January 26, 2024

Study Registration Dates

First Submitted

January 28, 2022

First Submitted That Met QC Criteria

March 2, 2022

First Posted (Actual)

March 3, 2022

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 10, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OG-8175A-023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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