Metformin for the Treatment of Endometrial Hyperplasia

Endometrial Hyperplasia Clinical Trial

Official title:

Metformin for the Treatment of Endometrial Hyperplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01685762
• Other study ID #: LCCC 1205
• Status: Completed
• Phase: Early Phase 1
• Start date: January 10, 2013
• Est. completion date: December 1, 2015

Study information

• Verified date: January 2019
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 1, 2015
• Est. primary completion date: December 1, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Hyperplasia
• Endometrial Hyperplasia Without Atypia
• Hyperplasia

Intervention

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).

Locations

Country	Name	City	State
United States	The University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Southern Pines Women's Health Center	Southern Pines	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate	Evaluation of hyperplasia resolution by comparison of pre- and post-treatment endometrial biopsies.	12 weeks
Secondary	Toxicity evaluation	Number of subjects who experience side effects	12 weeks
Secondary	Patient Compliance	Percentage of patients successfully completing metformin therapy.	12 weeks
Secondary	Potential molecular markers in response to treatment with Metformin	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.	12 weeks

External Links

•   UNC Lineberger Comprehensive Cancer Center