Status:
RECRUITING
Mirena for the Treatment of Nonatypical Endometrial Hyperplasia for 6 Months
Lead Sponsor:
Bayer
Conditions:
Endometrial Hyperplasia
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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)...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
November 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 3 2027
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT06904274
Start Date
November 24 2025
End Date
May 3 2027
Last Update
December 23 2025
Active Locations (80)
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1
UAB Medicine Center for Research in Women's Health
Birmingham, Alabama, United States, 35233
2
Women's Health Alliance of Mobile
Mobile, Alabama, United States, 36604
3
AMR - Mobile, AL
Mobile, Alabama, United States, 36608
4
Velocity Clinical Research - Mobile
Mobile, Alabama, United States, 36608