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NCT06904274 · ClinicalTrials.gov registry record · Phase 3
Mirena for the Treatment of Nonatypical Endometrial Hyperplasia for 6 Months
A Phase 3 study of Endometrial Hyperplasia, sponsored by Bayer.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 207
- Enrollment target
- 20
- Study locations
NCT06904274 is a Phase 3 study of Endometrial Hyperplasia that is actively recruiting participants, run by Bayer. The registered enrollment target is 207 participants. The trial reports 20 study locations across 6 states.
The verdict
NCT06904274, a Phase 3 study of Endometrial Hyperplasia, is actively recruiting participants, sponsored by Bayer.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 207 participants
- Enrollment target
- 20
- Study locations
Study Summary
Researchers are looking for a better way to treat women with nonatypical endometrial hyperplasia (NAEH). Endometrial hyperplasia is a condition where the lining of the uterus (called the endometrium) becomes too thick. Nonatypical means that the condition is not cancerous. It is often caused by hormone imbalances in women. Symptoms can include abnormal vaginal bleeding or irregular periods. If this condition is not treated, then it may lead to cancer. Currently, there are no approved treatments for NAEH and that is why there is still an unmet medical need. The study treatment, Mirena (also known as BAY 865028), is already available as a type of birth control device. It is inserted into the uterus where it gradually releases progesterone. In this study, researchers want to find out if Mirena works for women with NAEH. They believe it can help by keeping hormone levels balanced in the body. The main purpose of this study is to show that uterine lining goes back to completely normal lining after treatment with Mirena and that its use is safe in this population. For this, the researchers will compare the number of participants with benign endometrium after 6 months of treatment with Mirena or oral MPA. The study participants will be randomly assigned into one of two treatment groups. The randomization will be done 2:1 ratio, meaning that for every two participants assigned to Mirena, one will be assigned to oral medroxyprogesterone acetate (MPA). Based on their group, participants will receive Mirena, which is inserted into the uterus at the start of the study, or they will take progestins once daily by mouth for 6 months. Each participant will be in the study for around 10 months with up to 5 visits to the study clinic/site. Participants will visit the study clinic: * once before the treatment starts * 3 times with a gap of 3 months between the visits during the treatment * then 1 more time after the treatment ends During the study, the doctors and their stu
Conditions Studied
Interventions
- COMBINATION_PRODUCT BAY865028
- DRUG Medroxyprogesterone acetate
Study Locations (20)
Florida
- AMR - Fort Myers, FL - Fort Myers
- Sweet Hope Research Specialty, Inc. - Hialeah - Hialeah
- UF Health Women's Specialists - Emerson - Jacksonville
- New Age Medical Research Corp. - Miami
- K2 Medical Research - South Orlando - Orlando
- Entrust Clinical Research - Palmetto Bay
Alabama
- UAB Medicine Center for Research in Women's Health - Birmingham
- Women's Health Alliance of Mobile - Mobile
- AMR - Mobile, AL - Mobile
- Velocity Clinical Research - Mobile - Mobile
Arizona
- North Valley Women's Care - Glendale
- Mesa Obstetricians and Gynecologists | Research Department - Mesa
- Marchand OB/GYN - Mesa
- Velocity Clinical Research - Phoenix - Phoenix
California
- Velvet Clinical Research - Burbank
- Allen Clinical Research LLC - Gardena
- UC Davis Health Lawrence J Ellison Ambulatory Care Center - OB/GYN - Sacramento
- Alliance Clinical West Hills - West Hills
Arkansas
- Cornerstone Clinic for Women - Aldersgate - Little Rock
Colorado
- OB/GYN Department_Comprehensive Women's Health Center - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 207 participants |
| Start Date | 2025-11-24 |
| Est. Completion | 2027-05-03 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06904274
The ClinicalTrials.gov registry entry for NCT06904274 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 207 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Endometrial Hyperplasia appearing as the primary indexed condition, and to 2 interventions - of which BAY865028 is the first listed.
NCT06904274 reports 20 study locations spanning 6 distinct geographic areas - top geographies include Florida, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT06904274 about?
NCT06904274 is a clinical study titled "Mirena for the Treatment of Nonatypical Endometrial Hyperplasia for 6 Months". Researchers are looking for a better way to treat women with nonatypical endometrial hyperplasia (NAEH). Endometrial hyperplasia is a condition where the lining of the uterus (called the endometrium) becomes too thick. Nonatypical means that the condition is not cancerous. It is often caused by hor...
What is the current status of trial NCT06904274?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 207 participants. The study started on 2025-11-24. Estimated completion is 2027-05-03.
What conditions does trial NCT06904274 study?
This clinical trial studies the following conditions: Endometrial Hyperplasia.
What interventions are being tested in trial NCT06904274?
The interventions under investigation include: BAY865028 (COMBINATION_PRODUCT), Medroxyprogesterone acetate (DRUG).
Who is sponsoring clinical trial NCT06904274?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06904274 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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