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Mirena IUD treatment for nonatypical endometrial hyperplasia for 6 months

A Multi-center, Open Label, Randomized Parallel Group Study Evaluating the Proportion of Women With Complete Resolution of Nonatypical Endometrial Hyperplasia Treated With Mirena or Oral Medroxyprogesterone Acetate for 6 Months

PHASE3 · Bayer · NCT06904274

This study will see if the Mirena intrauterine device can return the uterine lining to normal in women with nonatypical endometrial hyperplasia over six months.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment207 (estimated)
Ages18 Years and up
SexFemale
SponsorBayer (industry)
Locations86 sites (Birmingham, Alabama and 85 other locations)
Trial IDNCT06904274 on ClinicalTrials.gov

What this trial studies

Adult women with histologically confirmed nonatypical endometrial hyperplasia will receive the levonorgestrel-releasing intrauterine system (Mirena/BAY 865028) or oral medroxyprogesterone acetate for six months. Endometrial samples are taken at screening (or within 42 days prior) and after treatment to determine whether the lining has returned to normal. Key exclusions include uterine anomalies that would prevent IUD placement, recent hormone therapy, and pregnancy. The study is phase 3, sponsored by Bayer, and conducted at sites in Birmingham and Mobile, Alabama.

Who should consider this trial

Good fit: Women aged 18 or older with histologically confirmed nonatypical endometrial hyperplasia who can undergo IUD placement and attend scheduled visits are ideal candidates.

Not a fit: Women with uterine or cervical abnormalities that prevent IUD insertion, recent use of hormonal treatments, or who are pregnant are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, Mirena could restore a normal endometrial lining and reduce the risk of progression to cancer while limiting systemic hormone exposure.

How similar studies have performed: Previous studies have shown levonorgestrel-releasing IUDs can be effective for treating endometrial hyperplasia, so this approach is supported by earlier evidence.

Eligibility criteria

Show full inclusion / exclusion criteria 
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).

Where this trial is running

Birmingham, Alabama and 85 other locations

+36 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Endometrial Hyperplasia

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.