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Metformin for the Treatment of Endometrial Hyperplasia

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ClinicalTrials.gov Identifier: NCT01685762
Recruitment Status : Active, not recruiting
First Posted : September 14, 2012
Last Update Posted : May 5, 2017
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

July 26, 2012
September 14, 2012
May 5, 2017
September 2012
December 1, 2015   (Final data collection date for primary outcome measure)
Response Rate [ Time Frame: 12 weeks ]
Evaluation of hyperplasia resolution by comparison of pre- and post-treatment endometrial biopsies.
Same as current
Complete list of historical versions of study NCT01685762 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
Metformin for the Treatment of Endometrial Hyperplasia
Metformin for the Treatment of Endometrial Hyperplasia
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.
Early Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Endometrial Hyperplasia
  • Endometrial Hyperplasia Without Atypia
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
Experimental: Metformin
Metformin once daily for 4 weeks (weeks 1-4) and then twice daily for 8 weeks (weeks 5-12).
Intervention: Drug: Metformin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Active, not recruiting
December 2018
December 1, 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
LCCC 1205
Not Provided
Not Provided
UNC Lineberger Comprehensive Cancer Center
UNC Lineberger Comprehensive Cancer Center
Not Provided
Principal Investigator: Victoria Bae-Jump, MD, PhD University of North Carolina, Chapel Hill
UNC Lineberger Comprehensive Cancer Center
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP