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Metformin for the Treatment of Endometrial Hyperplasia


Phase 0
18 Years
75 Years
Open (Enrolling)
Female
Endometrial Hyperplasia, Endometrial Hyperplasia Without Atypia

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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