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Metformin for the Treatment of Endometrial Hyperplasia

Primary Purpose

Endometrial Hyperplasia, Endometrial Hyperplasia Without Atypia

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Metformin

About this trial

This is an interventional treatment trial for Endometrial Hyperplasia focused on measuring Endometrial hyperplasia, Uterus, Pilot, Metformin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

The University of North Carolina at Chapel Hill
Southern Pines Women's Health Center
University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Metformin

Arm Description

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

Outcomes

Primary Outcome Measures

Response Rate

Evaluation of hyperplasia resolution by comparison of pre- and post-treatment endometrial biopsies.

Secondary Outcome Measures

Toxicity evaluation

Number of subjects who experience side effects

Patient Compliance

Percentage of patients successfully completing metformin therapy.

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.

Full Information

NCT ID

NCT01685762

First Posted

July 26, 2012

Last Updated

January 17, 2019

Sponsor

UNC Lineberger Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT01685762

Brief Title

Metformin for the Treatment of Endometrial Hyperplasia

Official Title

Metformin for the Treatment of Endometrial Hyperplasia

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

January 10, 2013 (Actual)

Primary Completion Date

December 1, 2015 (Actual)

Study Completion Date

December 1, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UNC Lineberger Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endometrial Hyperplasia, Endometrial Hyperplasia Without Atypia

Keywords

Endometrial hyperplasia, Uterus, Pilot, Metformin

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Metformin

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Metformin

Other Intervention Name(s)

Fortamet, Glucophage, Glumetza, Riomet

Intervention Description

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).

Primary Outcome Measure Information:

Title

Response Rate

Description

Evaluation of hyperplasia resolution by comparison of pre- and post-treatment endometrial biopsies.

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Toxicity evaluation

Description

Number of subjects who experience side effects

Time Frame

12 weeks

Title

Patient Compliance

Description

Percentage of patients successfully completing metformin therapy.

Time Frame

12 weeks

Title

Potential molecular markers in response to treatment with Metformin

Description

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.

Time Frame

12 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Victoria Bae-Jump, MD, PhD

Organizational Affiliation

University of North Carolina, Chapel Hill

Official's Role

Principal Investigator

Facility Information:

Facility Name

The University of North Carolina at Chapel Hill

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Facility Name

Southern Pines Women's Health Center

City

Southern Pines

State/Province

North Carolina

ZIP/Postal Code

28388

Country

United States

Facility Name

University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

12. IPD Sharing Statement

Links:

URL

http://unclineberger.org

Description

UNC Lineberger Comprehensive Cancer Center

Learn more about this trial

Metformin for the Treatment of Endometrial Hyperplasia

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