Metformin for the Treatment of Endometrial Hyperplasia

NCT ID: NCT01685762

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-10
• Study Completion Date: 2015-12-01

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.

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.

Conditions

Endometrial Hyperplasia; Endometrial Hyperplasia Without Atypia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Metformin

Metformin once daily for 4 weeks (weeks 1-4) and then twice daily for 8 weeks (weeks 5-12).

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

Other Intervention Names

Fortamet; Glucophage; Glumetza; Riomet

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Victoria Bae-Jump, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Southern Pines Women's Health Center

Southern Pines, North Carolina, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Related Links

http://unclineberger.org

UNC Lineberger Comprehensive Cancer Center

Other Identifiers

LCCC 1205

Identifier Type: -

Identifier Source: org_study_id