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Birth control IUD could treat Pre-Cancer uterine condition

NCT ID NCT06904274

Disease control Sponsor: Bayer 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 Results may not be published yet.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
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 31, 2026 · Updated 5 times

Summary

This study tests whether the Mirena IUD, a birth control device that releases hormones, can reverse a noncancerous thickening of the uterine lining better than daily hormone pills. About 207 women with nonatypical endometrial hyperplasia will be randomly assigned to get either Mirena or oral medroxyprogesterone for 6 months. The goal is to see whose uterine lining returns to normal.

What this could mean

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

Active substance
Mirena (levonorgestrel-releasing intrauterine system) and medroxyprogesterone acetate (oral tablet)
What this could lead to
If Mirena works, it could become a standard non-surgical treatment for noncancerous endometrial hyperplasia, helping women avoid more invasive procedures.
What could go wrong
This is a Phase 3 trial, but results may not confirm superiority over existing off-label treatments. The study is relatively small (207 participants) and does not assess long-term cancer prevention.

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.

Started

Nov 2025

Finished

Jun 2026

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

18 years and older

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: * Post-menarchal women (≥18 years) at the time of signing the informed consent. * Women with histologically confirmed NAEH independent of their parity or menopausal status. Endometrial samples will be obtained either at screening or no more than 42 days prior to the signing of the informed consent form. Exclusion Criteria: * Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results. * Congenital or acquired uterine or cervical anomaly including fibroids, or cervical stenosis that in the opinion of the investigator, would interfere with insertion and/or retention of the intrauterine system (i.e., if they distort the uterine cavity). * Use of any long-acting injectable sex-hormone preparations within 6 months prior to the start of study intervention, and /or short acting hormonal medication within 6 weeks prior to the start of study intervention. * Pregnancy * Participants with either known family or personal history of genetic predisposition to uterine, ovarian or colorectal cancers (e.g. Lynch syndrome).

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Conditions

The condition(s) this trial relates to.

Endometrial Hyperplasia endometrial hyperplasia without atypia

As listed by the trial registrant

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

Endometrial hyperplasia

Contacts and locations

Locations

  • AIH Research- Broadway

    Pearland, Texas, 77584, United States

  • Alliance Clinical West Hills

    West Hills, California, 91307, United States

  • Biopharma Informatic - West Houston

    Houston, Texas, 77043, United States

  • Bosque Women's Care | Albuquerque, NM

    Albuquerque, New Mexico, 87109, United States

  • Centres Investigation Clinique Mauricie

    Trois-Rivières, Quebec, G8T 7A1, Canada

  • Chattanooga Medical Research, LLC. | Chattanooga, TN

    Chattanooga, Tennessee, 37412, United States

  • Chengdu Women & Children's Central Hospital

    Chengdu, Sichuan, 610091, China

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, 100029, China

  • Chongqing Maternal and Child Health Care Hospital

    Chongqing, Chongqing Municipality, 401147, China

  • ClinOhio Research Services, LLC. | Columbus, OH

    Columbus, Ohio, 43213, United States

  • Cornerstone Clinic for Women - Aldersgate

    Little Rock, Arkansas, 72205, United States

  • Discovery Clinical Trials - Dallas

    Dallas, Texas, 75230, United States

  • Emerald Coast Clinical Research

    Panama City, Florida, 32405, United States

  • Entrust Clinical Research

    Palmetto Bay, Florida, 33176, United States

  • Jiangxi Maternal and Child Health Hospital

    Nanchang, Jiangxi, 330006, China

  • Lyndhurst Clinical Research

    Winston-Salem, North Carolina, 27103, United States

  • Mount Sinai Hospital Toronto | Gynecology

    Toronto, Ontario, M5G 1Z5, Canada

  • Nanjing Maternity and Child Health Care Hospital

    Nanjing, Jiangsu, 210004, China

  • Nanjing Medical University (NMU) - The Second Affiliated Hospital

    Nanjing, Jiangsu, 210011, China

  • New Age Medical Research Corp.

    Miami, Florida, 33186, United States

  • OB/GYN Associates of Erie

    Erie, Pennsylvania, 16507, United States

  • Office of Dr. Cindy Basinski, LLC

    Evansville, Indiana, 47715, United States

  • Omni Fertility and Laser Institute

    Shreveport, Louisiana, 71118, United States

  • Paramount Research Solutions | College Park Location

    Atlanta, Georgia, 30327, United States

  • Peking Union Medical College Hospital CAMS

    Beijing, Beijing Municipality, 100730, China

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518036, China

  • Revive Research Institute - Michigan - Women's Health

    Dearborn Heights, Michigan, 48127, United States

  • Shaanxi Provincial People's Hospital

    Xi'an, Shaanxi, 710068, China

  • Southern Clinical Research Associates

    Metairie, Louisiana, 70001, United States

  • Sweet Hope Research Specialty, Inc. - Hialeah

    Hialeah, Florida, 33016, United States

  • Tangshan Maternal and Child Health Care Hospital

    Tangshan, Hebei, 063014, China

  • The Ottawa Hospital, Riverside Campus - Department of Obstetrics, Gynecology and Newborn Care

    Ottawa, Ontario, K1H 7W9, Canada

  • The Third Affiliated Hospital of Southern Medical University - Gynecology Department

    Guangzhou, Guangdong, 510630, China

  • Unified Women's Clinical Research - Centre OB/GYN

    Raleigh, North Carolina, 27607, United States

  • Velocity Clinical Research - Lafayette

    Lafayette, Louisiana, 70508, United States

  • Velocity Clinical Research - Phoenix

    Phoenix, Arizona, 85006, United States

  • Women and Children's Hospital, Qingdao University - Gynecology department

    Qingdao, Shandong, 266034, China

  • Xiamen Maternity and Child Health Care Hospital - Gynecology Department

    Xiamen, Fujian, 361003, China

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