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Endometrial Hyperplasia | Metformin for the Treatment of Endometrial Hyperplasia

Endometrial Hyperplasia research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Endometrial Hyperplasia

Endometrial Hyperplasia Without Atypia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Metformin850 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).

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

Study Status

Active, not recruiting

Start Date: January 10, 2013

Completed Date: December 2018

Phase: Early Phase 1

Type: Interventional

Design:

Primary Outcome: Response Rate

Secondary Outcome: Toxicity evaluation

Study sponsors, principal investigator, and references

Principal Investigator: Victoria Bae-Jump, MD, PhD

Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01685762

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