Study on a Behavioral Program to Help Prevent Uterine Cancer and Preserve Fertility in Premenopausal Women with Obesity and Endometrial Hyperplasia

Sponsor: Washington University School of Medicine

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05903131

Provider View

This clinical trial is exploring a new approach that combines a weight loss program with hormone treatment to help prevent uterine cancer and preserve fertility in premenopausal women with obesity and endometrial hyperplasia.

Patient Parameters

Program Overview

The study aims to find out if combining a weight loss program with hormone treatment (progestin) can help prevent uterine cancer and preserve fertility in premenopausal women who are obese and have a condition called atypical endometrial hyperplasia (AEH). AEH can lead to uterine cancer, and while surgery can prevent cancer, it also causes infertility. Hormone treatments exist but don't always work and don't address obesity, a key cause of AEH. This study will test if adding a weight loss program to hormone treatment is more effective than hormone treatment alone.

Eligibility Criteria

Inclusion Criteria

  • Women diagnosed with complex atypical endometrial hyperplasia (AEH) or early-stage uterine cancer.
  • Women already receiving hormone treatment (progestin) for AEH or early-stage uterine cancer can participate.
  • Premenopausal women with a uterus.
  • Women aged 18 to 45 years.
  • Interested in preserving their uterus and/or fertility.
  • Body Mass Index (BMI) of 30 or higher.
  • Willing to have a hormone-releasing IUD placed if not already in use.
  • Able to understand and willing to sign a consent form to participate.

Exclusion Criteria

  • Currently receiving chemotherapy or radiation for any cancer.
  • Pregnant or breastfeeding women. A negative pregnancy test is required before starting the study.
  • Have an active pelvic infection or other medical reasons that prevent the use of an IUD.

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