Clinical Trial: Metformin for the Treatment of Endometrial Hyperplasia

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Metformin for the Treatment of Endometrial Hyperplasia

Brief 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.

Detailed Summary: 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.
Sponsor: UNC Lineberger Comprehensive Cancer Center

Current Primary Outcome: Response Rate [ Time Frame: 12 weeks ]

Evaluation of hyperplasia resolution by comparison of pre- and post-treatment endometrial biopsies.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Toxicity evaluation [ Time Frame: 12 weeks ]
    Number of subjects who experience side effects
  • Patient Compliance [ Time Frame: 12 weeks ]
    Percentage of patients successfully completing metformin therapy.
  • Potential molecular markers in response to treatment with Metformin [ Time Frame: 12 weeks ]
    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.


Original Secondary Outcome: Same as current

Information By: UNC Lineberger Comprehensive Cancer Center

Dates:
Date Received: July 26, 2012
Date Started: September 2012
Date Completion: December 2018
Last Updated: May 4, 2017
Last Verified: May 2017