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NOT YET RECRUITING
NCT07436793
PHASE2

Progestins for the Treatment of Endometrial Cancer or Precancers of the Uterus Before Surgery, The Pro-Window Trial

Sponsor: New Mexico Cancer Research Alliance

View on ClinicalTrials.gov

Summary

This phase II trial tests compares the effect of progestins, megestrol acetate to micronized progesterone, in treating patients with endometrial cancer and precancers of the uterus (atypical endometrial hyperplasia) before surgery. Progestins, similar to the natural hormone progesterone, are approved drugs used in birth control and hormone replacement pills, and some can treat uterine endometrial cancers. In the initial comparison of this rotating umbrella trial, megestrol acetate, a progestin, will be compared to micronized progesterone, a form of natural progesterone that is a hormone produced by body normally. Hormone therapy using megestrol acetate and micronized progesterone may be effective in treating patients with endometrial cancer or atypical endometrial hyperplasia before surgery, and understanding the tissue effects of each agent on the malignant endometrium will uncover novel mechanistic and biomarker data to understand how best to advanced hormone therapy for endometrial cancer.

Official title: Evaluating Promising Progestins in Endometrial Cancer Through a Rotating Umbrella Surgical Window Trial - The PRO-WINDOW TRIAL for Endometrial Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2026-03-01

Completion Date

2031-06-30

Last Updated

2026-02-27

Healthy Volunteers

No

Interventions

PROCEDURE

Biopsy Procedure

Undergo biopsy

PROCEDURE

Curettage Procedure

Undergo curettage

PROCEDURE

Hysterectomy

Undergo hysterectomy

DRUG

Megestrol Acetate

Given PO

DRUG

Progesterone Only Hormone Replacement Therapy

Given PO

Locations (4)

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

University of Utah Sugarhouse Health Center

Salt Lake City, Utah, United States

University of Virginia Cancer Center

Charlottesville, Virginia, United States