Metformin for the Treatment of Endometrial Hyperplasia - Full Text View

Purpose

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	Intervention	Phase
Endometrial Hyperplasia Endometrial Hyperplasia Without Atypia	Drug: Metformin	Phase 0


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Metformin for the Treatment of Endometrial Hyperplasia

Resource links provided by NLM:

Drug Information available for: Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:

Response Rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Evaluation of hyperplasia resolution by comparison of pre- and post-treatment endometrial biopsies.

Secondary Outcome Measures:

Toxicity evaluation [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Number of subjects who experience side effects
Patient Compliance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percentage of patients successfully completing metformin therapy.
Potential molecular markers in response to treatment with Metformin [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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.


Enrollment:	18
Study Start Date:	September 2012
Estimated Study Completion Date:	December 2018
Estimated Primary Completion Date:	December 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01685762

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

Additional Information:

UNC Lineberger Comprehensive Cancer Center This link exits the ClinicalTrials.gov site


Responsible Party:	UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT01685762 History of Changes
Other Study ID Numbers:	LCCC 1205
Study First Received:	July 26, 2012
Last Updated:	July 1, 2016
Health Authority:	United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 23, 2016