Metformin for the Treatment of Endometrial Hyperplasia
18 Years
75 Years
Female
Endometrial Hyperplasia, Endometrial Hyperplasia Without Atypia
Trial Information
Metformin for the Treatment of Endometrial Hyperplasia
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response Rate
Outcome Description:
Evaluation of hyperplasia resolution by comparison of pre- and post-treatment endometrial biopsies.
Outcome Time Frame:
12 weeks
Safety Issue:
No
Principal Investigator
Victoria Bae-Jump, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of North Carolina, Chapel Hill
Authority:
United States: Institutional Review Board
Study ID:
LCCC 1205
NCT ID:
NCT01685762
Start Date:
September 2012
Completion Date:
December 2014
Related Keywords:
- Endometrial Hyperplasia
- Endometrial Hyperplasia Without Atypia
- Endometrial hyperplasia
- Uterus
- Pilot
- Metformin
- Endometrial Hyperplasia
- Hyperplasia
- Adenoma
Name | Location |
|---|---|
| Southern Pines Women's Health Center | Southern Pines, North Carolina 28388-0749 |
| The University Of North Carolina At Chapel Hill | Chapel Hill, North Carolina 27599-7235 |
