OncoMatch/Clinical Trials/NCT05903131
Uterine Preservation Via Lifestyle Transformation
Is NCT05903131 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Progestin and Levonorgestrel-releasing IUD. for endometrial hyperplasia.
Treatment: Progestin · Levonorgestrel-releasing IUD. — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Endometrial Cancer
Disease stage
Grade: 1
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: progestin therapy (oral progestin, LNG-IUD) — prior or current
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.
Cannot have received: chemotherapy
Current, active treatment for any malignant neoplasm with chemotherapy or radiation
Cannot have received: radiation therapy
Current, active treatment for any malignant neoplasm with chemotherapy or radiation
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Washington University School of Medicine · St Louis, Missouri
- University of New Mexico · Albuquerque, New Mexico
- University of Oklahoma · Oklahoma City, Oklahoma
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