Metformin for the Treatment of Endometrial Hyperplasia

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center
• Treatments: Metformin

Criteria

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