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RECRUITING
NCT05903131
PHASE2

Uterine Preservation Via Lifestyle Transformation

Sponsor: Washington University School of Medicine

View on ClinicalTrials.gov

Summary

Up to 60% of endometrial cancer cases are attributed to obesity, in part because obesity promotes development of atypical endometrial hyperplasia (AEH), and up to 40% of women with AEH go on to develop endometrial cancer. The increasing prevalence of obesity in premenopausal women has resulted in increasing rates of AEH in this age group. Hysterectomy with removal of the fallopian tubes and ovaries is 100% effective in preventing endometrial cancer, but this approach results in infertility. Fertility-sparing treatments exist, such as treatment with oral or intrauterine progestin, but these treatments do not work uniformly and do not combat the underlying cause of endometrial cancer, which is obesity and metabolic syndrome. Additionally, up to 41% of women on progestin eventually experience relapse of AEH or endometrial cancer. Third, many patients have insulin resistance that may worsen with progestin therapy. Thus, to improve treatment of AEH and grade 1 endometrial cancer, prevent and reverse endometrial cancer, and allow women to preserve their fertility, the investigators must integrate an effective weight loss strategy to be given with progestin treatment. It is the hypothesis that premenopausal women with AEH desire uterine preservation will be more likely to have atypia-free uterine preservation at one year if they receive progestin in combination with a behavioral weight loss intervention versus progestin plus enhanced usual care.

Official title: UPLifT-Endo: Uterine Preservation Via Lifestyle Transformation A Behavioral Intervention to Promote Primary Prevention and Uterine Preservation in Premenopausal Women With Obesity and Atypical Endometrial Hyperplasia or Grade 1 Endometrial Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

96

Start Date

2024-10-24

Completion Date

2029-10-31

Last Updated

2026-01-20

Healthy Volunteers

No

Interventions

BEHAVIORAL

Telemedicine behavioral weight intervention

Weekly telephone calls during the first month, biweekly during the next 5 months, and then monthly for the last 7 months (12 months total). Each telephone session will be 30 minutes long.

DRUG

Progestin

Released via the levonorgestrel-releasing IUD.

BEHAVIORAL

Enhanced usual care

1-3 page handouts

DRUG

Levonorgestrel-releasing IUD.

Standard of care

Locations (3)

Washington University School of Medicine

St Louis, Missouri, United States

University of New Mexico

Albuquerque, New Mexico, United States

University of Oklahoma

Oklahoma City, Oklahoma, United States