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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluation of hyperplasia resolution by comparison of pre- and post-treatment endometrial biopsies.
Victoria Bae-Jump, MD, PhD
University of North Carolina, Chapel Hill
United States: Institutional Review Board
|Southern Pines Women's Health Center||Southern Pines, North Carolina 28388-0749|
|The University Of North Carolina At Chapel Hill||Chapel Hill, North Carolina 27599-7235|