Metformin for the Treatment of Endometrial Hyperplasia (NCT01685762) | Clinical Trial Compass
CompletedEarly Phase 1
Metformin for the Treatment of Endometrial Hyperplasia
United States18 participantsStarted 2013-01-10
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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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