This trial is active, not recruiting.

Conditions endometrial hyperplasia, endometrial hyperplasia without atypia
Treatment metformin
Phase phase 0
Sponsor UNC Lineberger Comprehensive Cancer Center
Start date September 2012
End date December 2016
Trial size 18 participants
Trial identifier NCT01685762, LCCC 1205


The purpose of this study is to see if metformin will be effective in making endometrial hyperplasia without atypia better by returning the tissue to a normal state.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Metformin once daily for 4 weeks (weeks 1-4) and then twice daily for 8 weeks (weeks 5-12).
metformin Fortamet
850 mg of metformin taken once daily by mouth for 4 weeks (weeks 1-4) and then twice daily by mouth for 8 weeks (weeks 5-12).

Primary Outcomes

Response Rate
time frame: 12 weeks

Secondary Outcomes

Toxicity evaluation
time frame: 12 weeks
Patient Compliance
time frame: 12 weeks
Potential molecular markers in response to treatment with Metformin
time frame: 12 weeks

Eligibility Criteria

Female participants from 18 years up to 75 years old.

Inclusion Criteria: - Be between the ages of 18-75 years old - Have a confirmed diagnosis of endometrial hyperplasia without atypia based upon endometrial biopsy - Have no contraindications to short-term metformin therapy - Have a creatinine clearance of ≥ 90 ml/min, as calculated by the Cockroft-Gault formula - Have normal serum transaminase values (AST and ALT) - Need to be able to undergo metformin treatment for a duration of 12 weeks prior to repeat endometrial biopsy Exclusion Criteria: - Are currently taking metformin or have taken metformin in the past 6 months or have a history of an allergic reaction or intolerance at any time to metformin - Have a history of liver or renal dysfunction. - Have a random glucose of ≤ 65 or ≥ 200 - Have a recent history of alcoholism. Former alcoholics who have abstained from alcohol for 5 years or more may be enrolled in this study. - Have a history of vitamin B12 deficiency - Are pregnant - Are currently taking insulin - Are taking a drug that may significantly interact or influence the metabolism of metformin - In the opinion of the investigator, the patient is felt not to be appropriate for the study

Additional Information

Official title Metformin for the Treatment of Endometrial Hyperplasia
Principal investigator Victoria Bae-Jump, MD, PhD
Description This is a multi-institutional pilot clinical trial designed to estimate the response rate and safety of metformin for the treatment of simple and complex endometrial hyperplasia (EH) without atypia. Enrollment of patients will occur at UNC-Chapel Hill and Southern Pines Women's Health Center. Fifteen patients will be enrolled over the course of 1 year. Metformin will be initiated at 850 mg orally once daily, and titrated up to twice daily over a minimum of 1 months time. Treatment will last 12 weeks and then patients will undergo repeat endometrial biopsy to assess for regression or persistence of EH.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center.