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

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
New Mexico Cancer Research Alliance
Study ID
NCT07436793
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Endometrial Endometrioid Adenocarcinoma
  • Endometrial Hyperplasia

Eligibility Criteria

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

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo biopsy
  • Curettage Procedure — PROCEDURE
    Undergo curettage
  • Hysterectomy — PROCEDURE
    Undergo hysterectomy
  • Megestrol Acetate — DRUG
    Given PO
  • Progesterone Only Hormone Replacement Therapy — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Mar 1, 2026
Status verified
Feb 2026
Primary completion
Jun 30, 2030
Completion
Jun 30, 2031

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm I (biopsy, curettage, MPA, hysterectomy)
    Patients undergo biopsy or curettage and then receive megestrol acetate PO BID 21-24 days prior to SOC hysterectomy on study.
  • Experimental: Arm II (biopsy, curettage, progesterone, hysterectomy)
    Patients undergo biopsy or curettage and then receive micronized progesterone PO QD beginning 21-24 days prior to SOC hysterectomy on study.

Primary Outcome Measure

Tissue response to progestin therapy [ Time Frame: From the time of pre treatment diagnostic biopsy to the time of post treatment hysterectomy specimen ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of Iowa/Holden Comprehensive Cancer CenterIowa CityIowa52242
Megan E. McDonald
[email protected]
Megan E. McDonald (PRINCIPAL_INVESTIGATOR)
University of New Mexico Cancer CenterAlbuquerqueNew Mexico87106
Carolyn Y. Muller
[email protected]
505-925-0461
Carolyn Y. Muller (PRINCIPAL_INVESTIGATOR)
University of Utah Sugarhouse Health CenterSalt Lake CityUtah84106
Kathryn Maurer
[email protected]
Kathryn Maurer (PRINCIPAL_INVESTIGATOR)
University of Virginia Cancer CenterCharlottesvilleVirginia22908
Linda R. Duska
[email protected]
Linda R. Duska (PRINCIPAL_INVESTIGATOR)

Find similar trials in Iowa City, IA

By research site
University of Iowa/Holden Comprehensive Cancer Center· Iowa City, IAUniversity of New Mexico Cancer Center· Albuquerque, NMUniversity of Utah Sugarhouse Health Center· Salt Lake City, UTUniversity of Virginia Cancer Center· Charlottesville, VA

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