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NCT04576104 · ClinicalTrials.gov registry record · Phase 2
Megestrol Acetate Compared With Megestrol Acetate and Metformin to Prevent Endometrial Cancer
A Phase 2 study of Endometrial Carcinoma and Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial Neoplasia, sponsored by Northwestern University.
- Active
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
- 8
- Study locations
NCT04576104: Active Phase 2 study of Endometrial Carcinoma and Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial Neoplasia, sponsored by Northwestern University.
NCT04576104 is a Phase 2 study of Endometrial Carcinoma and Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial Neoplasia that is active but no longer recruiting, run by Northwestern University. The registered enrollment target is 51 participants, below the 389-participant average among 27 other Endometrial Carcinoma trials with a reported enrollment target (87% lower). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04576104, a Phase 2 study of Endometrial Carcinoma and Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial Neoplasia, is active but no longer recruiting, sponsored by Northwestern University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
- 8
- Study locations
Study Summary
This phase II trial studies the effect of megestrol acetate alone or in combination with metformin in preventing the progression of uterine pre-cancer (endometrial intraepithelial neoplasia) to endometrial cancer. Megestrol acetate is a drug used to block estrogen and suppress the effects of estrogen and androgens. It is the current non-surgical treatment of endometrial intraepithelial neoplasia. Metformin is a drug that has been found to have anti-cancer properties. Giving metformin and megestrol acetate together may decrease the growth of endometrial intraepithelial neoplasia in the uterus better than megestrol alone.
Primary Outcome
Will measure the change in endometrial cell proliferation, as measured by the percentage of Ki-67 positive cells, in subjects treated with megestrol acetate + metformin compared to those treated with megestrol acetate alone, in all evaluable participants, and following stratification by menopausal status, as well as use of low dose, low potency progestins (yes/no).
Conditions Studied
Interventions
- PROCEDURE Biopsy Procedure
- OTHER Questionnaire Administration
- DRUG Extended Release Metformin Hydrochloride
- DRUG Megestrol Acetate
Study Locations (8)
Illinois
- Northwestern University - Chicago
- Northwestern Medicine Central DuPage Hospital - Winfield
North Carolina
- UNC Lineberger Comprehensive Cancer Center - Chapel Hill
- Duke University Medical Center - Durham
California
- Cedars Sinai Medical Center - Los Angeles
Colorado
- University of Colorado - Denver
Massachusetts
- Dana-Farber Cancer Institute - Boston
Minnesota
- University of Minnesota/Masonic Cancer Center - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2021-11-29 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 2 |
What the registry record for NCT04576104 still lists
NCT04576104 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 389-participant average among 27 other Endometrial Carcinoma trials with a reported enrollment target (87% lower).
The record links to 2 conditions, with Endometrial Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Biopsy Procedure is the first listed.
NCT04576104 lists 8 locations in 6 states (Illinois, North Carolina, California).
Frequently Asked Questions
What is clinical trial NCT04576104 about?
NCT04576104 is a clinical study titled "Megestrol Acetate Compared With Megestrol Acetate and Metformin to Prevent Endometrial Cancer". This phase II trial studies the effect of megestrol acetate alone or in combination with metformin in preventing the progression of uterine pre-cancer (endometrial intraepithelial neoplasia) to endometrial cancer. Megestrol acetate is a drug used to block estrogen and suppress the effects of estroge...
What is the current status of trial NCT04576104?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2021-11-29. Estimated completion is 2026-06-30.
What conditions does trial NCT04576104 study?
This clinical trial studies the following conditions: Endometrial Carcinoma, Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial Neoplasia.
What interventions are being tested in trial NCT04576104?
The interventions under investigation include: Biopsy Procedure (PROCEDURE), Questionnaire Administration (OTHER), Extended Release Metformin Hydrochloride (DRUG), Megestrol Acetate (DRUG).
Who is sponsoring clinical trial NCT04576104?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04576104 being conducted?
This trial has 8 study locations across California, Colorado, Illinois, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Endometrial Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04576104's enrollment target sits among peer trials
51 18th of 27 higher than 10 of 27 other Endometrial Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Endometrial Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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