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

NCT07436793 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-07-02

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • University of New Mexico Cancer Center

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • New Mexico Cancer Research Alliance

    lead OTHER

Principal Investigators

  • Carolyn Y Muller · University of New Mexico Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-15
Primary Completion
2030-06-30
Completion
2031-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07436793 on ClinicalTrials.gov