Metformin for the Treatment of Endometrial Hyperplasia



Status:Completed
Conditions:Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - 75
Updated:1/20/2019
Start Date:January 10, 2013
End Date:December 1, 2015

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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.

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
We found this trial at
3
sites
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Emily Ko, MD, MSCR
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Victoria Bae-Jump
Phone: 919-966-4432
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Southern Pines, North Carolina 28388
Principal Investigator: John Byron, MD
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Southern Pines, NC
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