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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
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).
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Southern Pines Women's Health Center
Southern Pines, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Response Rate
Evaluation of hyperplasia resolution by comparison of pre- and post-treatment endometrial biopsies.
Time frame: 12 weeks
Toxicity evaluation
Number of subjects who experience side effects
Time frame: 12 weeks
Patient Compliance
Percentage of patients successfully completing metformin therapy.
Time frame: 12 weeks
Potential molecular markers in response to treatment with Metformin
Compare changes in potential biomarkers, including metabolic factors and molecular markers of downstream targets of the metformin/mTOR signaling pathway, before and after metformin treatment.
Time frame: 12 weeks
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