Metformin for the Treatment of Endometrial Hyperplasia

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.

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