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Clinical trialNCT05903131RecruitingPhase 2Interventional

Uterine Preservation Via Lifestyle Transformation

SponsorWashington University School of MedicineEnrollment96Endometrial HyperplasiaGrade 1 Endometrial Cancer
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

  • Andrea R Hagemann, M.D., MSCI

    Washington University School of Medicine

    Principal Investigator

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

3 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Washington University School of Medicine

    St Louis, Missouri, United States

    Andrea R Hagemann, M.D., MSCIDavid Morris, Ph.D.David Mutch, M.D.Esther Lu, Ph.D.Gary Patii, Ph.D.Graham Colditz, M.D., DrPHIan Hagemann, M.D., Ph.D.Veronica Davé, Ph.D.
    Recruiting
  • University of New Mexico

    Albuquerque, New Mexico, United States

    Carolyn Muller, M.D.Kimberly Leslie, M.D.
    Recruiting
  • University of Oklahoma

    Oklahoma City, Oklahoma, United States

    Kathleen Moore, M.D., MS
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Levonorgestrel-releasing IUDProgesterone →
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
24 Oct 2024
Primary completion
31 Oct 2028
Completion
31 Oct 2029
Last update posted
20 Jan 2026
Registered enrollment
96
Registry id
NCT05903131

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.