Metformin for the Treatment of Endometrial Hyperplasia

Study Description

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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.

Study Design

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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
Study Start Date :	September 2012
Actual Primary Completion Date :	December 1, 2015
Estimated Study Completion Date :	December 2018

Arms and Interventions

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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

Outcome Measures

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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.

Eligibility Criteria

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

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Locations

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

Investigators

Principal Investigator:	Victoria Bae-Jump, MD, PhD	University of North Carolina, Chapel Hill

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

UNC Lineberger Comprehensive Cancer Center 

Responsible Party:	UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT01685762 History of Changes
Other Study ID Numbers:	LCCC 1205
First Posted:	September 14, 2012
Last Update Posted:	May 5, 2017
Last Verified:	May 2017

Keywords provided by UNC Lineberger Comprehensive Cancer Center:

Endometrial hyperplasia; Uterus; Pilot; Metformin

Additional relevant MeSH terms:

Hyperplasia; Endometrial Hyperplasia; Pathologic Processes; Uterine Diseases	Genital Diseases, Female; Metformin; Hypoglycemic Agents; Physiological Effects of Drugs