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New birth control pill study halted early – what we know

NCT ID NCT05264506

Disease control Sponsor: Organon and Co Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new combined oral contraceptive pill containing nomegestrol acetate and estradiol (NOMAC-E2) to prevent pregnancy. It enrolled over 3,000 women aged 14 to 35 who were at risk of pregnancy and wanted contraception. The trial was terminated early, so final results on effectiveness and safety are not available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nomegestrol acetate and estradiol (combined oral contraceptive pill)
What this could lead to
If successful, this pill could offer another safe and effective birth control option for women.
What could go wrong
The study was terminated early, so results are incomplete. As with any hormonal contraceptive, side effects like blood clots, mood changes, or irregular bleeding are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

3,055 people

The number who actually took part.

Started

Feb 2022

Finished

Jan 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

14 to 35 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contraception

Contacts and locations

Locations

  • Accel Research Sites - St. Petersburg Clinical Research Unit

    Largo, Florida, 33777, United States

  • Accurate Clinical Research, Inc

    Houston, Texas, 77065, United States

  • Admed Research, LLC

    Miami, Florida, 33173, United States

  • Advanced Investigative Medicine, Inc

    Hawthorne, California, 90250, United States

  • Agile Clinical Research Trials, LLC

    Atlanta, Georgia, 30328, United States

  • Alabama Clinical Therapeutics, LLC

    Birmingham, Alabama, 35235, United States

  • Albuquerque Clinical Trials, Inc

    Albuquerque, New Mexico, 87102, United States

  • Alliance Research Institute, LLC

    Canoga Park, California, 91304, United States

  • Alliance for Multispecialty Research

    Tempe, Arizona, 85281, United States

  • Alliance for Multispecialty Research, LLC

    Mobile, Alabama, 36608, United States

  • Alliance for Multispecialty Research, LLC

    Coral Gables, Florida, 33134, United States

  • Alliance for Multispecialty Research, LLC

    Fort Myers, Florida, 33912, United States

  • Alliance for Multispecialty Research, LLC

    El Dorado, Kansas, 67042, United States

  • Alliance for Multispecialty Research, LLC

    Newton, Kansas, 67114, United States

  • Alliance for Multispecialty Research, LLC

    Wichita, Kansas, 67205, United States

  • Alliance for Multispecialty Research, LLC

    Wichita, Kansas, 67207, United States

  • Alliance for Multispecialty Research, LLC

    New Orleans, Louisiana, 70119, United States

  • Alliance for Multispecialty Research, LLC

    Kansas City, Missouri, 64114, United States

  • Alliance for Multispecialty Research, LLC

    Las Vegas, Nevada, 89119, United States

  • Alliance for Multispecialty Research, LLC

    Knoxville, Tennessee, 37909, United States

  • Alliance for Multispecialty Research, LLC

    Norfolk, Virginia, 23502, United States

  • Alliance for Multispecialty Research, LLC - Lexington

    Lexington, Kentucky, 40509, United States

  • Altus Research, Inc.

    Lake Worth, Florida, 33461, United States

  • Avantis Clinical Research, LLC

    Miami, Florida, 33155, United States

  • Bosque Women's Care

    Albuquerque, New Mexico, 87109, United States

  • CMR of Greater New Haven, LLC

    Hamden, Connecticut, 06517, United States

  • Carolina Institute For Clinical Research

    Fayetteville, North Carolina, 28303, United States

  • Carolina Women's Research and Wellness Center

    Durham, North Carolina, 27713, United States

  • Cedar Health Research

    Dallas, Texas, 75251, United States

  • Chattanooga Medical Research, LLC

    Chattanooga, Tennessee, 37404, United States

  • Clinical Research Center of Florida

    Pompano Beach, Florida, 33060, United States

  • Clinical Research of Philadelphia, LLC

    Philadelphia, Pennsylvania, 19114, United States

  • Clinical Trial Network

    Houston, Texas, 77074, United States

  • Comprehensive Clinical Research, LLC

    West Palm Beach, Florida, 33409, United States

  • Continental Clinical Solutions

    Towson, Maryland, 21204, United States

  • Desert Clinical Research, LLC/CCT Research

    Mesa, Arizona, 85213, United States

  • Eclipse Clinical Research

    Tucson, Arizona, 85745, United States

  • Empire Clinical Research

    Pomona, California, 91767, United States

  • Essential Women's Health Associates

    Las Vegas, Nevada, 89113, United States

  • Exordia Medical Research, Inc

    Fall River, Massachusetts, 02723, United States

  • Gardens Medical Center / Alliance Research Institute

    Bell Gardens, California, 90201, United States

  • Genoma Research Group, Inc.

    Miami, Florida, 33173, United States

  • Healthcare Clinical Data, Inc.

    North Miami, Florida, 33161, United States

  • Helios Clinical Research

    Burleson, Texas, 76028, United States

  • Helios Clinical Research

    Fort Worth, Texas, 76104, United States

  • Helios Clinical Research - Weatherford

    Weatherford, Texas, 76086, United States

  • Infinite Clinical Trials

    Morrow, Georgia, 30260, United States

  • Innovation Medical Research Center

    Palmetto Bay, Florida, 33157, United States

  • Javara Inc

    Houston, Texas, 77054, United States

  • Javara Inc

    Sugar Land, Texas, 77478, United States

  • Javara Inc / Privia Medical Group Georgia, LLC

    Pooler, Georgia, 31322, United States

  • Javara Research

    Stephenville, Texas, 76401, United States

  • Javara Research

    Forest, Virginia, 24551, United States

  • Jubilee Clinical Research, Inc

    Las Vegas, Nevada, 89106, United States

  • Leavitt Clinical Research

    Idaho Falls, Idaho, 83404, United States

  • M3 Wake Research, Inc

    Raleigh, North Carolina, 27612, United States

  • Marvel Clinical Research

    Huntington Beach, California, 92647, United States

  • Meridian Clinical Research, LLC

    Vestal, New York, 13850, United States

  • Mesa Obstetricians and Gynecologists

    Mesa, Arizona, 85206, United States

  • Miami Clinical Research

    Miami, Florida, 33155, United States

  • NECCR PrimaCare Research, LLC

    Fall River, Massachusetts, 02721, United States

  • New Age Medical Research Corporation

    Miami, Florida, 33186, United States

  • New Phase Research & Development

    Knoxville, Tennessee, 37909, United States

  • Noble Clinical Research

    Tucson, Arizona, 85704, United States

  • OB-GYN Associates of Mid-Florida, PA

    Leesburg, Florida, 34748, United States

  • OB/GYN Associates of Erie

    Erie, Pennsylvania, 16507, United States

  • Om Research LLC

    Lancaster, California, 93534, United States

  • Physicians' Research Options / Red Rocks OB/GYN

    Lakewood, Colorado, 80228, United States

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

    Perth Amboy, New Jersey, 08861, United States

  • Precision Trials AZ, LLC

    Phoenix, Arizona, 85032, United States

  • Quality Research of South Florida

    Miami Lakes, Florida, 33016, United States

  • Quantum Clinical Trials

    Miami Beach, Florida, 33140, United States

  • R & B Medical Center LLC

    Tampa, Florida, 33614, United States

  • SEC Clinical Research

    Dothan, Alabama, 36305, United States

  • Seattle Clinical Research Center

    Seattle, Washington, 98105, United States

  • Sensible Healthcare LLC

    Ocoee, Florida, 34761, United States

  • Southern Clinical Research Associates

    Metairie, Louisiana, 70001, United States

  • Spotlight Research Center, LLC

    Miami, Florida, 33176, United States

  • Tekton Research, Inc

    Austin, Texas, 78705, United States

  • Tekton Research, Inc

    San Antonio, Texas, 78229, United States

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

    Rowlett, Texas, 75088, United States

  • The Iowa Clinic

    Ankeny, Iowa, 50023, United States

  • Tidewater Clinical Research

    Norfolk, Virginia, 23502, United States

  • Universal Axon Clinical Research, LLC

    Doral, Florida, 33166, United States

  • University of Cincinnati Physicians

    Cincinnati, Ohio, 45267, United States

  • Velocity Clinical Research

    Mobile, Alabama, 36608, United States

  • Velocity Clinical Research

    Denver, Colorado, 80209, United States

  • Velocity Clinical Research

    Lafayette, Louisiana, 70508, United States

  • Velocity Clinical Research

    Metairie, Louisiana, 70006, United States

  • Velocity Clinical Research

    Slidell, Louisiana, 70458, United States

  • Velocity Clinical Research

    Gulfport, Mississippi, 39503, United States

  • Velocity Clinical Research

    Grand Island, Nebraska, 68803, United States

  • Velocity Clinical Research

    Hastings, Nebraska, 68901, United States

  • Velocity Clinical Research

    Omaha, Nebraska, 68134, United States

  • Velocity Clinical Research - Covington

    Covington, Louisiana, 70433, United States

  • Velocity Clinical Research - Phoenix

    Phoenix, Arizona, 85006, United States

  • Venus Gynecology, LLC

    Myrtle Beach, South Carolina, 29572, United States

  • WR-Medical Center For Clinical Research - San Diego

    San Diego, California, 92120, United States

  • WR-Medical Research Center of Memphis

    Memphis, Tennessee, 38120, United States

  • WR-Mount Vernon Clinical Research, LLC

    Sandy Springs, Georgia, 30328, United States

  • WR-Women's Health Care Research, LLC

    San Diego, California, 92111, United States

  • Wasatch Clinical Research

    Salt Lake City, Utah, 84107, United States

  • Women's Healthcare Associates P.A.

    Idaho Falls, Idaho, 83404, United States

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