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ContraceptionPhase 3NCT05264506

Contraceptive Efficacy and Safety of NOMAC-E2 Combined Oral Contraceptive

A Phase 3 study testing NOMAC-E2 COC in people with Contraception, run by Organon and Co at 103 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 14 to 35 years, women only
Conditions the study is for
Contraception
What is being tested?
NOMAC-E2 COC
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,055 participants
Where
103 sitesUnited States
Study dates
17 Feb 2022to 26 Jan 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 35 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 27Show fewer
  • 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

Trial locations and contacts

103 sites in 1 country.

103 sites in 1 country

United States103 sites

  • Albuquerque Clinical Trials, Inc

    Albuquerque, New Mexico, 87102

  • Bosque Women's Care

    Albuquerque, New Mexico, 87109

  • The Iowa Clinic

    Ankeny, Iowa, 50023

  • Agile Clinical Research Trials, LLC

    Atlanta, Georgia, 30328

  • Tekton Research, Inc

    Austin, Texas, 78705

  • Gardens Medical Center / Alliance Research Institute

    Bell Gardens, California, 90201

  • Alabama Clinical Therapeutics, LLC

    Birmingham, Alabama, 35235

  • Helios Clinical Research

    Burleson, Texas, 76028

  • Alliance Research Institute, LLC

    Canoga Park, California, 91304

  • Chattanooga Medical Research, LLC

    Chattanooga, Tennessee, 37404

  • University of Cincinnati Physicians

    Cincinnati, Ohio, 45267

  • Alliance for Multispecialty Research, LLC

    Coral Gables, Florida, 33134

  • Velocity Clinical Research - Covington

    Covington, Louisiana, 70433

  • Cedar Health Research

    Dallas, Texas, 75251

  • Velocity Clinical Research

    Denver, Colorado, 80209

  • Universal Axon Clinical Research, LLC

    Doral, Florida, 33166

  • SEC Clinical Research

    Dothan, Alabama, 36305

  • Carolina Women's Research and Wellness Center

    Durham, North Carolina, 27713

  • Alliance for Multispecialty Research, LLC

    El Dorado, Kansas, 67042

  • OB/GYN Associates of Erie

    Erie, Pennsylvania, 16507

  • NECCR PrimaCare Research, LLC

    Fall River, Massachusetts, 02721

  • Exordia Medical Research, Inc

    Fall River, Massachusetts, 02723

  • Carolina Institute For Clinical Research

    Fayetteville, North Carolina, 28303

  • Javara Research

    Forest, Virginia, 24551

  • Alliance for Multispecialty Research, LLC

    Fort Myers, Florida, 33912

  • Helios Clinical Research

    Fort Worth, Texas, 76104

  • Velocity Clinical Research

    Grand Island, Nebraska, 68803

  • Velocity Clinical Research

    Gulfport, Mississippi, 39503

  • CMR of Greater New Haven, LLC

    Hamden, Connecticut, 06517

  • Velocity Clinical Research

    Hastings, Nebraska, 68901

  • Advanced Investigative Medicine, Inc

    Hawthorne, California, 90250

  • Javara Inc

    Houston, Texas, 77054

  • Accurate Clinical Research, Inc

    Houston, Texas, 77065

  • Clinical Trial Network

    Houston, Texas, 77074

  • Marvel Clinical Research

    Huntington Beach, California, 92647

  • Leavitt Clinical Research

    Idaho Falls, Idaho, 83404

  • Women's Healthcare Associates P.A.

    Idaho Falls, Idaho, 83404

  • Alliance for Multispecialty Research, LLC

    Kansas City, Missouri, 64114

  • Alliance for Multispecialty Research, LLC

    Knoxville, Tennessee, 37909

  • New Phase Research & Development

    Knoxville, Tennessee, 37909

  • Velocity Clinical Research

    Lafayette, Louisiana, 70508

  • Altus Research, Inc.

    Lake Worth, Florida, 33461

  • Physicians' Research Options / Red Rocks OB/GYN

    Lakewood, Colorado, 80228

  • Om Research LLC

    Lancaster, California, 93534

  • Accel Research Sites - St. Petersburg Clinical Research Unit

    Largo, Florida, 33777

  • Jubilee Clinical Research, Inc

    Las Vegas, Nevada, 89106

  • Essential Women's Health Associates

    Las Vegas, Nevada, 89113

  • Alliance for Multispecialty Research, LLC

    Las Vegas, Nevada, 89119

  • OB-GYN Associates of Mid-Florida, PA

    Leesburg, Florida, 34748

  • Alliance for Multispecialty Research, LLC - Lexington

    Lexington, Kentucky, 40509

  • WR-Medical Research Center of Memphis

    Memphis, Tennessee, 38120

  • Mesa Obstetricians and Gynecologists

    Mesa, Arizona, 85206

  • Desert Clinical Research, LLC/CCT Research

    Mesa, Arizona, 85213

  • Southern Clinical Research Associates

    Metairie, Louisiana, 70001

  • Velocity Clinical Research

    Metairie, Louisiana, 70006

  • Avantis Clinical Research, LLC

    Miami, Florida, 33155

  • Miami Clinical Research

    Miami, Florida, 33155

  • Admed Research, LLC

    Miami, Florida, 33173

  • Genoma Research Group, Inc.

    Miami, Florida, 33173

  • Spotlight Research Center, LLC

    Miami, Florida, 33176

  • New Age Medical Research Corporation

    Miami, Florida, 33186

  • Quantum Clinical Trials

    Miami Beach, Florida, 33140

  • Quality Research of South Florida

    Miami Lakes, Florida, 33016

  • Alliance for Multispecialty Research, LLC

    Mobile, Alabama, 36608

  • Velocity Clinical Research

    Mobile, Alabama, 36608

  • Infinite Clinical Trials

    Morrow, Georgia, 30260

  • Venus Gynecology, LLC

    Myrtle Beach, South Carolina, 29572

  • Alliance for Multispecialty Research, LLC

    New Orleans, Louisiana, 70119

  • Alliance for Multispecialty Research, LLC

    Newton, Kansas, 67114

  • Alliance for Multispecialty Research, LLC

    Norfolk, Virginia, 23502

  • Tidewater Clinical Research

    Norfolk, Virginia, 23502

  • Healthcare Clinical Data, Inc.

    North Miami, Florida, 33161

  • Sensible Healthcare LLC

    Ocoee, Florida, 34761

  • Velocity Clinical Research

    Omaha, Nebraska, 68134

  • Innovation Medical Research Center

    Palmetto Bay, Florida, 33157

  • Planned Parenthood of Northern, Central, and Southern New Jersey

    Perth Amboy, New Jersey, 08861

  • Clinical Research of Philadelphia, LLC

    Philadelphia, Pennsylvania, 19114

  • Velocity Clinical Research - Phoenix

    Phoenix, Arizona, 85006

  • Precision Trials AZ, LLC

    Phoenix, Arizona, 85032

  • Empire Clinical Research

    Pomona, California, 91767

  • Clinical Research Center of Florida

    Pompano Beach, Florida, 33060

  • Javara Inc / Privia Medical Group Georgia, LLC

    Pooler, Georgia, 31322

  • M3 Wake Research, Inc

    Raleigh, North Carolina, 27612

  • Texas Health Care, PLLC d/b/d Privia Medical Group - North Texas

    Rowlett, Texas, 75088

  • Wasatch Clinical Research

    Salt Lake City, Utah, 84107

  • Tekton Research, Inc

    San Antonio, Texas, 78229

  • WR-Women's Health Care Research, LLC

    San Diego, California, 92111

  • WR-Medical Center For Clinical Research - San Diego

    San Diego, California, 92120

  • WR-Mount Vernon Clinical Research, LLC

    Sandy Springs, Georgia, 30328

  • Seattle Clinical Research Center

    Seattle, Washington, 98105

  • Velocity Clinical Research

    Slidell, Louisiana, 70458

  • Javara Research

    Stephenville, Texas, 76401

  • Javara Inc

    Sugar Land, Texas, 77478

  • R & B Medical Center LLC

    Tampa, Florida, 33614

  • Alliance for Multispecialty Research

    Tempe, Arizona, 85281

  • Continental Clinical Solutions

    Towson, Maryland, 21204

  • Noble Clinical Research

    Tucson, Arizona, 85704

  • Eclipse Clinical Research

    Tucson, Arizona, 85745

  • Meridian Clinical Research, LLC

    Vestal, New York, 13850

  • Helios Clinical Research - Weatherford

    Weatherford, Texas, 76086

  • Comprehensive Clinical Research, LLC

    West Palm Beach, Florida, 33409

  • Alliance for Multispecialty Research, LLC

    Wichita, Kansas, 67205

  • Alliance for Multispecialty Research, LLC

    Wichita, Kansas, 67207

Other trials in United States

About this study

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)

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).

Read the 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.

Conditions
Contraception
Being tested
NOMAC-E2 COC
Keywords
Birth control methods, Contraceptive, Postmenarcheal Premenopausal Women, Hormonal, Sexually Active

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NOMAC-E2 COCDrug

    Also called Nomegestrol acetate / estradiol

    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.

Study groups in NCT05264506
Study groupRoleWhat they receive
Nomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)ExperimentalThe 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.
Receives: Drug: NOMAC-E2 COC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With On-treatment Pregnancies

    Raw count of the number of pregnancies that occurred while participants were taking study drug

    Measured: 1 year

Secondary outcomes (13)

  1. Proportion of Participants With an Adverse Event (Regardless on Potential Relationship to Study Drug)

    Measured: 1 year

  2. Proportion of Participants Who Prematurely Discontinue Study Drug Treatment

    Measured: 1 year

  3. Percentage of Participants With On-treatment Pregnancies 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

    Measured: 1 year

  4. Number of Cycles of Exposure Prior to Pregnancy

    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)

    Measured: 1 year

  5. Number of Participants With a Pregnancy, Based on Baseline BMI Categories (<30 kg/m2, ≥30 kg/m2)

    Raw count of the number of pregnancies that occurred while participants were taking study drug in each BMI category

    Measured: 1 year

  6. Proportion of Participants With Bleeding-spotting Days

    Number of participants with bleeding-spotting days as a proportion of the number of participants who had at least one completed cycle

    Measured: 28-day cycles across one year

  7. Mean Number of Bleeding and/or Spotting Days Per Cycle

    For participants who had at least one completed cycle, the mean number of bleeding-spotting days per cycle

    Measured: 28-day cycles across one year

  8. Average Number of Bleeding-spotting Days Per Reference Period

    For participants with at least one completed reference period, the average number of bleeding-spotting days per reference period

    Measured: 91-day reference periods across one year

  9. Proportion of Participants With 8 or More Bleeding-spotting Days

    Proportion of participants who had at least one completed cycle with 8 or more bleeding-spotting days in a cycle

    Measured: 28-day cycles across one year

  10. Mean NOMAC Concentration, Visit 3 Pre-Dose

    NOMAC concentrations assessed through use of sparse sampling

    Measured: Treatment Week 5

  11. Mean NOMAC Concentration, Visit 3 Post-Dose

    NOMAC concentrations assessed through use of sparse sampling

    Measured: Treatment Week 5

  12. Mean NOMAC Concentration, Visit 4 Pre-Dose

    NOMAC concentrations assessed through use of sparse sampling

    Measured: Treatment Week 17

  13. Mean NOMAC Concentration, Visit 4 Post-Dose

    NOMAC concentrations assessed through use of sparse sampling

    Measured: Treatment Week 17

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2022
  2. Study start17 Feb 2022
  3. Primary completion12 Jan 2024
  4. Study completion26 Jan 2024

Why it 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Single Arm Study
Masking
None (open label)
Enrolment
3,055 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05264506
Sponsor's protocol ID
OG-8175A-023
Status last verified
Sep 2025
First submitted
28 Jan 2022
Last updated
21 Nov 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NOMAC-E2 COC in people with Contraception, run by Organon and Co at 103 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 103 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With On-treatment Pregnancies (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05264506.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.

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