A Behavioral Intervention to Promote Primary Prevention and Uterine Preservation in Premenopausal Women With Obesity and Endometrial Hyperplasia

Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Jun 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to help women with obesity who have been diagnosed with a condition called atypical endometrial hyperplasia (AEH) or grade 1 endometrial cancer. The goal is to see if combining progestin treatment (a type of hormone therapy) with a weight loss program can help prevent the progression of these conditions while allowing women to keep their uterus and preserve their ability to have children. This is important because traditional treatments like surgery can lead to infertility, and many current treatments do not effectively address the underlying issue of obesity.

To participate in the trial, women must be between 18 and 45 years old, premenopausal, and have a confirmed diagnosis of AEH or grade 1 endometrial cancer. They should also have a body mass index (BMI) of 30 or higher, indicating obesity, and be interested in preserving their uterus and fertility. Participants can expect to receive support for weight loss along with their hormone treatment, and they will be closely monitored for changes in their condition over the year. This trial is currently recruiting participants, and it aims to provide a more effective and less invasive treatment option for women facing these health challenges.

Gender

FEMALE

Eligibility criteria

• 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.
• • Interested in uterine preservation and/or fertility-sparing treatment.
• • 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.