Behavioral intervention for weight management in premenopausal women with obesity and endometrial hyperplasia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate a behavioral intervention designed to promote primary prevention and uterine preservation in premenopausal women diagnosed with atypical endometrial hyperplasia or grade 1 endometrial cancer. The study will utilize telemedicine to provide weight management support alongside progestin therapy and enhanced usual care. By addressing obesity, which is a significant risk factor for endometrial cancer, the trial seeks to improve treatment outcomes and reduce the need for hysterectomy. Participants will be monitored for their response to the intervention and the effectiveness of fertility-sparing treatments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

• Washington University School of Medicine
  St Louis, Missouri, United States Recruiting
• University of New Mexico
  Albuquerque, New Mexico, United States Recruiting
• University of Oklahoma
  Oklahoma City, Oklahoma, United States Recruiting

Study contacts

• Principal investigator: Andrea R Hagemann, M.D., MSCI — Washington University School of Medicine
• Study coordinator: Andrea R Hagemann, M.D., MSCI
• Email: hagemanna@wustl.edu
• Phone: 314-362-1763

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Progestins before surgery for endometrial cancer or precancers

  This phase II study tests two progestin options (megestrol acetate vs. micronized progesterone) for women with endometrial cancer or atypical endometrial hyperplasia before they have surgery.

  Recruiting at 2 sites Phase 2 New Mexico Cancer Research Alliance · Iowa City, Iowa and 3 other locations · NCT07436793

• Fertility-preserving hysteroscopic treatment outcomes for endometrial cancer and atypical hyperplasia

  This project tests whether removing lesions by hysteroscopy combined with hormonal therapy helps women with endometrial cancer or atypical hyperplasia preserve fertility and achieve good pregnancy and cancer-control outcomes.

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Roma · NCT07077876

• Tracking outcomes of uterine cavity conditions after hysteroscopy

  This project will follow adults with endometrial polyps, hyperplasia, or cancer who undergo hysteroscopy to see if detailed clinical and pathology data can predict disease course over one year.

  Recruiting Tongji Hospital · Wuhan, Hubei · NCT07048327

• Using ultrasound to guide endometrial biopsies for post-menopausal bleeding

  This study is testing if using ultrasound to guide endometrial biopsies can help women with post-menopausal bleeding get better tissue samples and avoid more invasive procedures.

  Recruiting Imperial College Healthcare NHS Trust · London · NCT06501846

• Evaluating a fertility-preserving treatment for early-stage endometrial cancer and hyperplasia

  This study is testing a new treatment for early-stage endometrial cancer and hyperplasia to see if it can help women of childbearing age preserve their fertility while managing their condition.

  Recruiting Women's Hospital School Of Medicine Zhejiang University · Hangzhou, Zhejiang · NCT06417736

• Fertility preservation for women with endometrial cancer and hyperplasia

  This study is testing a new surgery to help younger women with early-stage endometrial cancer or hyperplasia keep their ability to have children instead of needing a hysterectomy.

  Recruiting Vancouver Coastal Health Research Institute · Vancouver, British Columbia · NCT04362046

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.