Hormone showdown: which progestin best tames uterine cancer before surgery?
NCT ID NCT07436793
First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This study compares two hormone drugs (megestrol acetate and micronized progesterone) in 140 women with endometrial cancer or precancer. Participants take one of the drugs for a short time before their scheduled surgery. Researchers will measure how well each drug slows cancer cell growth and look for clues about why one might work better. The goal is to improve hormone therapy for this type of cancer.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 140 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Jun 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Iowa/Holden Comprehensive Cancer Center
RECRUITINGIowa City, Iowa, 52242, United States
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University of New Mexico Cancer Center
RECRUITINGAlbuquerque, New Mexico, 87106, United States
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University of Utah Sugarhouse Health Center
NOT_YET_RECRUITINGSalt Lake City, Utah, 84106, United States
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University of Virginia Cancer Center
NOT_YET_RECRUITINGCharlottesville, Virginia, 22908, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Hormone blockers and letrozole tested to spare uterus in early endometrial cancer
- Hormone combo tested as Fertility-Sparing option for early uterine cancer
- Can a Weight-Loss drug boost Fertility-Sparing cancer treatment?
- Could a common Weight-Loss drug help hormone therapy work better for young women with endometrial cancer?
- Ice pack on the belly may ease pain after keyhole hysterectomy
- Can weight management plus hormones reverse precancerous uterine changes and preserve fertility?