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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01685762
Other study ID # LCCC 1205
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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