Primary Prevention and Uterine Preservation in Premenopausal Women With Obesity and Endometrial Hyperplasia

NCT05829460 · Withdrawn

Last updated 2026-05-28

This clinical trial is testing whether a treatment can prevent endometrial hyperplasia in premenopausal women with obesity while preserving the uterus.

Status Withdrawn Stopped before any participant enrolled.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Who can join Ages 18–45 · female only

Timeline Started 2025-03 · est. completion 2032-04

What this study is testing ClinicalTrials.gov NCT05829460 ↗

Description as written by the study sponsor.

The investigators hypothesize that combined treatment with the GLP-1R agonist semaglutide 2.4 mg and levonorgestrel intrauterine device (LNG-IUD), compared to LNG-IUD alone, will result in improved likelihood of uterine preservation, sustained weight loss, improved endometrial and metabolomic response to progestin, and improved quality of life in premenopausal women with endometrial hyperplasia who desire uterine preservation.

Treatments tested

Semaglutide Drug

This medication is self-administered as a subcutaneous injection in the abdomen, thigh, or upper arm; injection site should be rotated when using the same body region.
Placebo Drug

This medication is self-administered as a subcutaneous injection in the abdomen, thigh, or upper arm; injection site should be rotated when using the same body region.
LNG-IUD (Progestin) Drug

Released via the levonorgestrel-releasing IUD.
Telemedicine behavioral weight program Behavioral

Optional to attend.

Main thing measured	Number of patients with endometrial hyperplasia free biopsy with uterine preservation
Sponsor	Washington University School of Medicine
Conditions studied	Endometrial Hyperplasia
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT05829460 ↗