Megestrol Acetate Compared With Megestrol Acetate and Metformin to Prevent Endometrial Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
Northwestern University
Study ID
NCT04576104
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo biopsy
  • Extended Release Metformin Hydrochloride — DRUG
    Given PO
  • Megestrol Acetate — DRUG
    Given PO
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Nov 29, 2021
Status verified
Jan 2026
Primary completion
Aug 28, 2025
Completion
Jun 30, 2026

Study Design

Enrollment
51 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Arm I (megestrol acetate)
    Prior to standard of care planned procedure, patients receive megestrol acetate PO BID for 21-35 days (up to and including the night before planned procedure) in the absence of disease progression or unacceptable toxicity. Patients also undergo biopsy on the day of planned procedure.
  • Experimental: Arm II (megestrol acetate, metformin hydrochloride)
    Prior to standard of care planned procedure, patients receive megestrol acetate PO BID and metformin hydrochloride extended-release PO BID for 21-35 days (up to and including the night before planned procedure) in the absence of disease progression or unacceptable toxicity. Patients also undergo biopsy on the day of planned procedure.

Primary Outcome Measure

Percentage of Ki-67 positive cells [ Time Frame: Up to 42 days post planned procedure ]

Locations (8)

FacilityCityStateZIPSite coordinators
Cedars Sinai Medical CenterLos AngelesCalifornia90048-
University of ColoradoDenverColorado80217-3364-
Northwestern UniversityChicagoIllinois60611-
Northwestern Medicine Central DuPage HospitalWinfieldIllinois60190-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
University of Minnesota/Masonic Cancer CenterMinneapolisMinnesota55455-
UNC Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599-
Duke University Medical CenterDurhamNorth Carolina27710-

Find similar trials in Los Angeles, CA

By condition
Endometrial cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Cedars Sinai Medical Center· Los Angeles, CAUniversity of Colorado· Denver, CONorthwestern University· Chicago, ILNorthwestern Medicine Central DuPage Hospital· Winfield, ILDana-Farber Cancer Institute· Boston, MAUniversity of Minnesota/Masonic Cancer Center· Minneapolis, MN

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