Metformin for the Treatment of Endometrial Hyperplasia

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by UNC Lineberger Comprehensive Cancer Center
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center Identifier:
First received: July 26, 2012
Last updated: August 26, 2015
Last verified: August 2015
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.

Condition Intervention Phase
Endometrial Hyperplasia
Endometrial Hyperplasia Without Atypia
Drug: Metformin
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Metformin for the Treatment of Endometrial Hyperplasia

Resource links provided by NLM:

Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • Response Rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Evaluation of hyperplasia resolution by comparison of pre- and post-treatment endometrial biopsies.

Secondary Outcome Measures:
  • Toxicity evaluation [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Number of subjects who experience side effects

  • Patient Compliance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Percentage of patients successfully completing metformin therapy.

  • Potential molecular markers in response to treatment with Metformin [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.

Estimated Enrollment: 15
Study Start Date: September 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metformin
Metformin once daily for 4 weeks (weeks 1-4) and then twice daily for 8 weeks (weeks 5-12).
Drug: Metformin
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).
Other Names:
  • Fortamet
  • Glucophage
  • Glumetza
  • Riomet

Detailed Description:
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.

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01685762

Contact: Mark Bozymski 919-966-4432
Contact: Donna Rowe, RN 919-966-7359

United States, North Carolina
The University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Mark Bozymski    919-966-4432   
Principal Investigator: Victoria Bae-Jump         
Sub-Investigator: Emily Ko, MD         
Southern Pines Women's Health Center Recruiting
Southern Pines, North Carolina, United States, 28388
Principal Investigator: John Byron, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19107
Principal Investigator: Emily Ko, MD, MSCR         
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Principal Investigator: Victoria Bae-Jump, MD, PhD University of North Carolina, Chapel Hill
  More Information

Additional Information:
Responsible Party: UNC Lineberger Comprehensive Cancer Center Identifier: NCT01685762     History of Changes
Other Study ID Numbers: LCCC 1205 
Study First Received: July 26, 2012
Last Updated: August 26, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
Endometrial hyperplasia

Additional relevant MeSH terms:
Endometrial Hyperplasia
Genital Diseases, Female
Pathologic Processes
Uterine Diseases
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on May 26, 2016