A Study to Learn How Well Mirena Works as Compared to Oral Progestin in Nonatypical Endometrial Hyperplasia in Women Who Have Started Their Periods

Launched by BAYER · Mar 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how well a device called Mirena works in treating women with a condition known as nonatypical endometrial hyperplasia (NAEH), which is when the lining of the uterus becomes too thick but is not cancerous. Currently, women with this condition are often treated with oral progestins, which are hormone pills taken by mouth. The researchers want to see if Mirena, which is already used for birth control and releases hormones directly in the uterus, may be a better treatment option for balancing hormone levels and improving symptoms.

To participate in the study, women must be at least 16 years old and have been diagnosed with NAEH. Participants will be placed into two groups: one will receive Mirena, while the other will take oral progestins for about six months. Throughout the trial, participants will have several clinic visits to monitor their health, undergo tests, and share how they are feeling. The trial aims to find out if Mirena can help improve the condition more effectively than the oral treatment. This study is not yet recruiting participants, but it provides an opportunity to explore new treatment options for NAEH.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Post-menarchal women (≥ 16-years) at the time of signing the informed consent.
• • Women with histologically confirmed NAEH independent of their parity or menopausal status.
• 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).