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

Phase 3

Not yet recruiting

• Conditions: Endometrial Hyperplasia
• Interventions: Combination Product: BAY865028; Drug: Medroxyprogesterone acetate

• Registration Number: NCT06904274
• Lead Sponsor: Bayer

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) 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, oral progestins (OP) which are progesterone (female hormone) capsules taken by mouth, are used to treat NAEH. However, there is still a need for other treatments due to unmet needs.

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 learn how well Mirena works compared to oral in NAEH in women who have started their periods.

For this, the researchers will compare the number of participants with benign endometrium after 6 months of treatment with Mirena or oral progestins.

The study participants will be randomly divided equally into one of two treatment groups. 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 study team will:

* check participant's health by performing tests such as blood and urine tests

* perform vaginal ultrasound and hysteroscopy. Hysteroscopy is a minor surgical procedure where a thin camera will be inserted into the womb to check for any abnormality. Sampling of the endometrial lining (cells in the womb) will be done with a thin tube at the same time.

* take samples of womb (endometrial) lining

* ask the participants questions about how they are feeling and what adverse events they are having

An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-21
• Study First Submitted QC: 2025-03-24
• Study First Posted: 2025-04-01
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-14
• Last Update Posted: 2025-07-16
• Study Start: 2025-09-05
• Primary Completion: 2027-01-06
• Study Completion: 2027-01-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 300

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levonorgestrel (BAY865028, Mirena)	BAY865028	Mirena will be inserted into the participant's uterus by the investigator on Day 1. At visit 4 (after 6 months) or if a participant discontinues her study participation prematurely, the Mirena will be removed by the investigator.
Oral progestin	Medroxyprogesterone acetate	Participants will receive 10mg oral progestin once daily, preferably always at the same time of the day, until visit 4 (after 6 months).

Primary Outcome Measures

Name	Time	Method
Proportion of participants with Complete Resolution (CR) of NAEH	At 6 months	Complete Resolution will be evaluated as benign endometrium.

Secondary Outcome Measures

Name	Time	Method
Recurrence of NAEH after CR	At 3 months follow up after 6 months treatment	Recurrence of NAEH on 3 months treatment free after CR at 6 months
Progression after CR	At 3 months follow up after 6 months treatment	Endometrial hyperplasia with atypia or endometrial cancer after 3 months treatment free follow up after CR at 6 months
Proportion of participants having hysterectomy	During treatment and 3 months follow up
Diagnosis of "benign endometrium"	At 6 months of treatment followed by 3 month treatment-free follow up
Number of participants with adverse events	From the signing of the informed consent form (ICF) up to 3 months after the last dose of study intervention	All AEs will be coded using the latest version prior to database lock of the Medical Dictionary for Regulatory Activities

Trial Locations

Locations (54)

UC Davis Health Lawrence J Ellison Ambulatory Care Center - OB/GYN; 🇺🇸 Sacramento, California, United States

UVA Health Midlife Health and Gynecologic Specialties Northridge; 🇺🇸 Charlottesville, Virginia, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Women's Health Alliance of Mobile; 🇺🇸 Mobile, Alabama, United States

AMR - Mobile, AL; 🇺🇸 Mobile, Alabama, United States

Mesa Obstetricians and Gynecologists | Research Department; 🇺🇸 Mesa, Arizona, United States

Cornerstone Clinic for Women; 🇺🇸 Little Rock, Arkansas, United States

Velvet Clinical Research; 🇺🇸 Burbank, California, United States

Allen Clinical Research LLC; 🇺🇸 Gardena, California, United States

AMR - Fort Myers, FL; 🇺🇸 Fort Myers, Florida, United States

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