Metformin for the Treatment of Endometrial Hyperplasia
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ClinicalTrials.gov Identifier: NCT01685762 |
Recruitment Status
:
Active, not recruiting
First Posted
: September 14, 2012
Last Update Posted
: May 5, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Endometrial Hyperplasia Endometrial Hyperplasia Without Atypia | Drug: Metformin | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 18 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Metformin for the Treatment of Endometrial Hyperplasia |
Study Start Date : | September 2012 |
Actual Primary Completion Date : | December 1, 2015 |
Estimated Study Completion Date : | December 2018 |
Arm | Intervention/treatment |
---|---|
Experimental: Metformin
Metformin once daily for 4 weeks (weeks 1-4) and then twice daily for 8 weeks (weeks 5-12).
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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:
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- Response Rate [ Time Frame: 12 weeks ]Evaluation of hyperplasia resolution by comparison of pre- and post-treatment endometrial biopsies.
- Toxicity evaluation [ Time Frame: 12 weeks ]Number of subjects who experience side effects
- Patient Compliance [ Time Frame: 12 weeks ]Percentage of patients successfully completing metformin therapy.
- Potential molecular markers in response to treatment with Metformin [ Time Frame: 12 weeks ]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.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01685762
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 |
Principal Investigator: | Victoria Bae-Jump, MD, PhD | University of North Carolina, Chapel Hill |
Additional Information:
Responsible Party: | UNC Lineberger Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT01685762 History of Changes |
Other Study ID Numbers: |
LCCC 1205 |
First Posted: | September 14, 2012 Key Record Dates |
Last Update Posted: | May 5, 2017 |
Last Verified: | May 2017 |
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 |