Megestrol Acetate Compared With Megestrol Acetate and Metformin to Prevent Endometrial Cancer (NCT04576104)
🩺 Plain-English Summary (8th-Grade Level)
This phase II trial studies the effect of megestrol acetate alone or in combination with metformin in preventing the progression of uterine pre-cancer (endometrial intraepithelial neoplasia) to endometrial cancer. Megestrol acetate is a drug used to block estrogen and suppress the effects of estrogen and androgens. It is the current non-surgical treatment of endometrial intraepithelial neoplasia. Metformin is a drug that has been found to have anti-cancer properties. Giving metformin and megestrol acetate together may decrease the growth of endometrial intraepithelial neoplasia in the uterus better than megestrol alone.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (14 items) and avoid the listed exclusions (21 items).
Location: Cedars Sinai Medical Center — Los Angeles, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Current hormonal contraceptives or post-menopausal hormone replacement therapy, and uses of progestins (including progestin containing intrauterine device \[IUD\]) EXCEPT FOR:
- Megestrol acetate up to and including 40 mg daily
- Medroxyprogesterone acetate up to and including 10 mg daily
- Norethindrone acetate up to and including 10 mg daily
- Norethindrone up to and including 0.35 mg daily
- Oral micronized progesterone up to and including 30 0mg daily These low potency and lower dose progestins are permitted provided they have been used for less than 8 weeks (56 days) prior to enrollment and were started after the pre-treatment biopsy (e.g. endometrial biopsy or dilation and curettage). Participants will discontinue these low potency and lower dose progestins at the time of enrollment NOTES: Vaginal estrogen use is permitted. Prior use of hormonal contraceptives or post-menopausal hormone therapy is allowed, provided that it was discontinued \> 3 months from current EIN diagnosis.
- Current use of selective estrogen receptor modulators (SERMs) and aromatase inhibitors. Prior use of SERMs or aromatase inhibitors is allowed, provided that it was discontinued \> 3 months from current EIN diagnosis
- Current use of metformin therapy (prior use of metformin therapy is allowed, provided that it was discontinued \> 1 year from trial enrollment)
- Use of GLP-1 or dual GLP-1/GIP-1 receptor agonists within 6 weeks prior to the baseline diagnostic biopsy or randomization
- Participants receiving any other investigational agents within 30 days of enrollment or during this study.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to metformin or megestrol acetate
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (8 Sites)
- Cedars Sinai Medical Center — Los Angeles, California
- University of Colorado — Denver, Colorado
- Northwestern University — Chicago, Illinois
- Northwestern Medicine Central DuPage Hospital — Winfield, Illinois
- Dana-Farber Cancer Institute — Boston, Massachusetts
- University of Minnesota/Masonic Cancer Center — Minneapolis, Minnesota
- UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina
- Duke University Medical Center — Durham, North Carolina
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.