Metformin for the Treatment of Endometrial Hyperplasia

This study is currently recruiting participants.
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
  Purpose

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 2014
Estimated Primary Completion Date: December 2014 (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.

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01685762

Contacts
Contact: Mark Bozymski 919-966-4432 mark_bozymski@med.unc.edu
Contact: Donna Rowe, RN 919-966-7359 donna_rowe@med.unc.edu

Locations
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    mark_bozymski@med.unc.edu   
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
Investigators
Principal Investigator: Victoria Bae-Jump, MD, PhD University of North Carolina, Chapel Hill
  More Information

Additional Information:
No publications provided

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01685762     History of Changes
Other Study ID Numbers: LCCC 1205
Study First Received: July 26, 2012
Last Updated: April 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
Endometrial hyperplasia
Uterus
Pilot
Metformin

Additional relevant MeSH terms:
Endometrial Hyperplasia
Hyperplasia
Uterine Diseases
Genital Diseases, Female
Pathologic Processes
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014