Study Summary
This trial is testing whether a combination of two drugs, megestrol acetate and metformin, is more effective than megestrol acetate alone in preventing the progression of uterine pre-cancer (endometrial intraepithelial neoplasia) to endometrial cancer.
Eligible Conditions
- Endometrial Cancer
- Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial Neoplasia
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: Up to 42 days post surgery
Baseline
Ki-67 expression
Day 42
Changes in protein expression
Day 42
Percentage of Ki-67 positive cells
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
2 Treatment Groups
Arm I (megestrol acetate)
1 of 2
Arm II (megestrol acetate, metformin hydrochloride)
1 of 2
Active Control
Experimental Treatment
50 Total Participants · 2 Treatment Groups
Primary Treatment: Megestrol Acetate · No Placebo Group · Phase 2
Arm II (megestrol acetate, metformin hydrochloride)Experimental Group · 3 Interventions: Megestrol Acetate, Questionnaire Administration, Extended Release Metformin Hydrochloride · Intervention Types: Drug, Other, Drug
Arm I (megestrol acetate)ActiveComparator Group · 3 Interventions: Biopsy, Megestrol Acetate, Questionnaire Administration · Intervention Types: Procedure, Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Megestrol acetate
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 42 days post surgery
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,098 Previous Clinical Trials
41,145,727 Total Patients Enrolled
70 Trials studying Endometrial Cancer
70,467 Patients Enrolled for Endometrial Cancer
Emma BarberPrincipal InvestigatorNorthwestern University
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Patients must have completed treatment and achieved a cured status for hepatitis C virus infection, or be currently on treatment with an undetectable HCV viral load.
You are eligible for the study if you have been diagnosed with EIN on an endometrial biopsy or dilation and curettage specimen within three months prior to enrollment, including terms such as complex atypical hyperplasia and atypical hyperplasia.
You must be 18 or older to participate in this study, as EIN is largely experienced by adults and there is insufficient data available about the effects of megestrol acetate on participants younger than 18.
Your ECOG performance status is less than or equal to 2 and your Karnofsky score is greater than or equal to 60%.
Your total bilirubin levels are at or below the upper limit of what is considered normal for your healthcare provider.
Your AST/ALT ratio is equal to or less than 3.0 times the institutional upper limit of normal.
Your creatinine level is at or below the recommended maximum for your institution.
Individuals who are HIV-positive and have undetectable viral load after receiving anti-retroviral therapy for at least 6 months are qualified to participate in this trial.
Patients with chronic HBV must have an undetectable viral load, if suppressive therapy is prescribed.
Individuals receiving long-term antiviral medication for HSV infection are eligible.
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Conditions
Cancer Related
Treatments