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Progestins for Endometrial Cancer or Precancers Before Surgery

This study, called The Pro-Window Trial, is looking at how well two different progestin medications, megestrol acetate and micronized progesterone, work to treat endometrial cancer or precancerous conditions of the uterus (atypical endometrial hyperplasia) before surgery. Progestins are similar to the natural hormone progesterone and are already used in some medications. You may be able to join if you are a woman aged 18 or older with a confirmed diagnosis of endometrioid endometrial adenocarcinoma or atypical endometrial hyperplasia. The study aims to see how your tissue responds to the progestin therapy between your initial biopsy and your hysterectomy. The current recruitment status is unclear, and the study plans to enroll 140 participants.

Study design
This is an interventional study where 140 participants will be randomly assigned to receive either megestrol acetate or micronized progesterone.
What's involved
You would have a biopsy or curettage, then take either megestrol acetate or micronized progesterone orally for 21-24 days before having a hysterectomy.
Compensation
Not stated in the trial record.
Follow-up
You will be followed up for 30-45 days after your surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07436793

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
New Mexico Cancer Research Alliance
~140 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:Biopsy ProcedureCurettage ProcedureHysterectomyMegestrol AcetateProgesterone Only Hormone Replacement Therapy

At a glance

Recruiting sites
2 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Tissue response to progestin therapy
Measured over From the time of pre treatment diagnostic biopsy to the time of post treatment hysterectomy specimen

Conditions

Endometrial Endometrioid Adenocarcinoma
Endometrial Hyperplasia

Explore related trials

Endometrial Endometrioid AdenocarcinomaEndometrial Hyperplasia

Where it's being run

4 sites across 4 states
Iowa1
New Mexico1
Utah1
Virginia1

Study leadership

  • Carolyn Y Muller · PRINCIPAL_INVESTIGATOR · University of New Mexico Cancer Center

Who to contact

Megan E. McDonald
[email protected]
319-356-2015
Email the study team

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Eligibility criteria

Inclusion

Patients must have a histologically proven diagnosis of endometrioid endometrial adenocarcinoma by endometrial curettage or biopsy within 8 weeks prior to registration. Pathology reports should document adequate tissue from the biopsy and slides should be reasonable determined to be obtainable by the study team for study use
History/physical examination within 42 +/- 5 days of planned surgical procedure (18-21 days from day 1)
Age ≥ 18
The trial is open only to women with primary endometrioid adenocarcinoma of the uterine corpus (all histologic grades and stages) who are planned and appropriate for primary surgical treatment to include removal of the uterine corpus via any surgical modality. The patient must be considered a suitable surgical candidate
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2, or 3 within 28 days prior to registration
Formalin-fixed, paraffin-embedded tumor tissue from the biopsy or curettage must be reasonably deemed available for submission along with the corresponding pathology report
Platelets ≥ 100,000/μl
Granulocytes (absolute neutrophil count \[ANC\]) ≥ 1,500/μl
Creatinine ≤ 1.6 mg/dl
Serum glutamic-pyruvic transaminase (SGPT) (alanine transaminase \[ALT\]) ≤ 3 x upper limits of normal
Bilirubin within institutional normal limits
The patient must provide study-specific informed consent and authorization permitting release of personal health information prior to study entry
Any patients of childbearing potential must have a negative pregnancy test

Exclusion

Patients with any non-endometrioid histology (such as serous, clear cell, or carcinosarcoma or mixed)
Patients who have received prior progestin or anti-estrogen therapy during the 3 months before the diagnosis of endometrioid adenocarcinoma of the uterine corpus is established. Estrogen therapy alone is allowed
Patients with ECOG performance status of 4
Patients with history of deep venous thrombosis or pulmonary embolism within the past 2 years or ongoing thromboembolic disorders
Patients who have previously received systemic, radiation or other treatment for uterine cancer
Patients for whom formalin-fixed, paraffin-embedded tumor tissue from the biopsy or curettage is scant or unavailable
Patients with a suspected or known peanut allergy
Patients with serious comorbidities or gastrointestinal obstruction that precludes taking oral medications or have malabsorptive disease

What this trial measures

  • Tissue response to progestin therapyFrom the time of pre treatment diagnostic biopsy to the time of post treatment hysterectomy specimen

    Will be determined by a change in the percentage in the expression of the proliferative marker Ki-67 comparing the pretreatment diagnostic biopsy to the posttreatment hysterectomy specimen. Immunohistochemical evaluation of Ki-67 protein expression will be determined as a continuous variable using the percent of cells staining positive in the nucleus