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Uterine Preservation Via Lifestyle Transformation for Endometrial Hyperplasia or Grade 1 Endometrial Cancer

This study is for women with atypical endometrial hyperplasia (AEH) or grade 1 endometrial cancer. It aims to see if a telemedicine behavioral weight intervention, combined with a levonorgestrel-releasing IUD (a device that releases progestin, a hormone), can help preserve the uterus. Some participants will receive the telemedicine intervention and IUD, while others will receive enhanced usual care (handouts) and the IUD. Researchers want to find out how many participants are free of AEH after one year. This study is exploring ways to manage these conditions without surgery, especially for women who want to maintain their fertility. The current recruitment status is unclear, but the study plans to enroll 96 participants.

Study design
This is an interventional study with 96 planned participants. It compares a telemedicine behavioral weight intervention plus a levonorgestrel-releasing IUD to enhanced usual care plus a levonorgestrel-releasing IUD.
What's involved
Participants receiving the telemedicine behavioral weight intervention will have weekly telephone calls for the first month, biweekly for the next 5 months, and then monthly for 7 months (12 months total). Each call will be 30 minutes long. All participants will receive a levonorgestrel-releasing IUD.
Compensation
Not stated in the trial record.
Follow-up
Participants will be assessed at 1 year to see if they are free of atypical endometrial hyperplasia.

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NCT05903131

Uterine Preservation Via Lifestyle Transformation

Recruiting
PHASE2Ages 18+InterventionalTreatment
Washington University School of Medicine
~96 participants
Updated 2026-01-20 on ClinicalTrials.gov
What's tested:Telemedicine behavioral weight interventionProgestinEnhanced usual careLevonorgestrel-releasing IUD.

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with atypical endometrial hyperplasia (AEH)-free biopsy
Measured over At 1 year

Conditions

Endometrial Hyperplasia
Grade 1 Endometrial Cancer

Explore related trials

Endometrial CarcinomaEndometrial Hyperplasia

Where it's being run

3 sites across 3 states
Missouri1
New Mexico1
Oklahoma1

Study leadership

  • Andrea R Hagemann, M.D., MSCI · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

Who to contact

Andrea R Hagemann, M.D., MSCI
[email protected]
314-362-1763
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Eligibility criteria

Inclusion

Diagnosis of histologically confirmed complex atypical endometrial hyperplasia (AEH) or grade 1 endometrial cancer.
Patients with a previous diagnosis of AEH or grade 1 endometrial cancer who are already being followed with conservative management with oral or LNG-IUD progestin therapy are eligible.
For patients with a previous diagnosis of AEH or grade 1 endometrial cancer who have been placed on progestin prior to study entry, the duration of IUD or oral progestin use prior to trial entry should be documented.
Premenopausal woman with a uterus.
ECOG performance status of 0-2.
At least 18 years of age and no more than 45 years of age.
Undergoing uterine-sparing management (e.g. due to interest in fertility preservation, interest in uterine preservation, provider recommendation, or other reason).
BMI ≥ 30 kg/m\^2.
Prior or current receipt of progestin is allowed as above. Willingness to undergo placement of LNG-IUD at the time of study entry.
Ability to understand and willingness to sign an IRB approved written informed consent document.

Exclusion

Current, active treatment for any malignant neoplasm with chemotherapy or radiation.
Pregnant and/or breastfeeding. Participants must have a negative urine or serum pregnancy test during screening window and within 7 days prior to LNG-IUD insertion. If LNG-IUD is in place, lack of pregnancy is assumed.
Active pelvic infection at the time of IUD placement or other contraindication to the use of an IUD in the opinion of the treating physician.

What this trial measures

  • Number of participants with atypical endometrial hyperplasia (AEH)-free biopsyAt 1 year