Metformin for the Treatment of Endometrial Hyperplasia

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by UNC Lineberger Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01685762
First received: July 26, 2012
Last updated: April 14, 2014
Last verified: April 2014

July 26, 2012
April 14, 2014
September 2012
December 2014   (final data collection date for primary outcome measure)
Response Rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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 ] [ 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.
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.

Interventional
Phase 0
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Recruiting
15
December 2014
December 2014   (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
Female
18 Years to 75 Years
No
Contact: Mark Bozymski 919-966-4432 mark_bozymski@med.unc.edu
Contact: Donna Rowe, RN 919-966-7359 donna_rowe@med.unc.edu
United States
 
NCT01685762
LCCC 1205
Yes
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
April 2014

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