NCT01685762

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jan 2013

Typical duration for early_phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 14, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

January 10, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 27, 2025

Status Verified

January 1, 2019

Enrollment Period

2.9 years

First QC Date

July 26, 2012

Last Update Submit

April 23, 2025

Conditions

Endometrial HyperplasiaEndometrial Hyperplasia Without Atypia

Keywords

Endometrial hyperplasiaUterusPilotMetformin

Outcome Measures

Primary Outcomes (1)

  • Response Rate

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

    12 weeks

Secondary Outcomes (3)

  • Toxicity evaluation

    12 weeks

  • Patient Compliance

    12 weeks

  • Potential molecular markers in response to treatment with Metformin

    12 weeks

Study Arms (1)

Metformin

EXPERIMENTAL

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

Drug: Metformin

Interventions

MetforminDRUG

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).

Also known as: Fortamet, Glucophage, Glumetza, Riomet
Metformin

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Southern Pines Women's Health Center

Southern Pines, North Carolina, 28388, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

MeSH Terms

Conditions

Endometrial Hyperplasia

Interventions

Metformin

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Victoria Bae-Jump, MD, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2012

First Posted

September 14, 2012

Study Start

January 10, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

April 27, 2025

Record last verified: 2019-01

Locations

US(3)