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Metformin for the Treatment of Endometrial Hyperplasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01685762
Recruitment Status : Completed
First Posted : September 14, 2012
Last Update Posted : January 18, 2019
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Endometrial Hyperplasia Endometrial Hyperplasia Without Atypia Drug: Metformin Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Metformin for the Treatment of Endometrial Hyperplasia
Actual Study Start Date : January 10, 2013
Actual Primary Completion Date : December 1, 2015
Actual Study Completion Date : December 1, 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Response Rate [ Time Frame: 12 weeks ]
    Evaluation of hyperplasia resolution by comparison of pre- and post-treatment endometrial biopsies.

Secondary Outcome Measures :
  1. Toxicity evaluation [ Time Frame: 12 weeks ]
    Number of subjects who experience side effects

  2. Patient Compliance [ Time Frame: 12 weeks ]
    Percentage of patients successfully completing metformin therapy.

  3. 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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01685762

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United States, North Carolina
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Southern Pines Women's Health Center
Southern Pines, North Carolina, United States, 28388
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
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Principal Investigator: Victoria Bae-Jump, MD, PhD University of North Carolina, Chapel Hill

Additional Information:
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Responsible Party: UNC Lineberger Comprehensive Cancer Center Identifier: NCT01685762    
Other Study ID Numbers: LCCC 1205
First Posted: September 14, 2012    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
Endometrial hyperplasia
Additional relevant MeSH terms:
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Endometrial Hyperplasia
Pathologic Processes
Uterine Diseases
Genital Diseases, Female
Hypoglycemic Agents
Physiological Effects of Drugs