Metformin for the Treatment of Endometrial Hyperplasia
This study is currently recruiting participants.
(see Contacts and Locations)
Verified April 2014 by UNC Lineberger Comprehensive Cancer Center
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01685762
First received: July 26, 2012
Last updated: April 14, 2014
Last verified: April 2014
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Endometrial Hyperplasia Endometrial Hyperplasia Without Atypia |
Drug: Metformin |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Metformin for the Treatment of Endometrial Hyperplasia |
Resource links provided by NLM:
Further study details as provided by UNC Lineberger Comprehensive Cancer Center:
Primary Outcome Measures:
- Response Rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Evaluation of hyperplasia resolution by comparison of pre- and post-treatment endometrial biopsies.
Secondary Outcome Measures:
- Toxicity evaluation [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]Number of subjects who experience side effects
- Patient Compliance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Percentage of patients successfully completing metformin therapy.
- Potential molecular markers in response to treatment with Metformin [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 15 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Metformin
Metformin once daily for 4 weeks (weeks 1-4) and then twice daily for 8 weeks (weeks 5-12).
|
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:
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01685762
Please refer to this study by its ClinicalTrials.gov identifier: NCT01685762
Contacts
| Contact: Mark Bozymski | 919-966-4432 | mark_bozymski@med.unc.edu | |
| Contact: Donna Rowe, RN | 919-966-7359 | donna_rowe@med.unc.edu |
Locations
| United States, North Carolina | |
| The University of North Carolina at Chapel Hill | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Contact: Mark Bozymski 919-966-4432 mark_bozymski@med.unc.edu | |
| Principal Investigator: Victoria Bae-Jump | |
| Sub-Investigator: Emily Ko, MD | |
| Southern Pines Women's Health Center | Recruiting |
| Southern Pines, North Carolina, United States, 28388 | |
| Principal Investigator: John Byron, MD | |
| United States, Pennsylvania | |
| University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Principal Investigator: Emily Ko, MD, MSCR | |
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
| Principal Investigator: | Victoria Bae-Jump, MD, PhD | University of North Carolina, Chapel Hill |
More Information
Additional Information:
No publications provided
| Responsible Party: | UNC Lineberger Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01685762 History of Changes |
| Other Study ID Numbers: | LCCC 1205 |
| Study First Received: | July 26, 2012 |
| Last Updated: | April 14, 2014 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
|
Endometrial hyperplasia Uterus Pilot Metformin |
Additional relevant MeSH terms:
|
Endometrial Hyperplasia Hyperplasia Genital Diseases, Female Pathologic Processes Uterine Diseases |
Metformin Hypoglycemic Agents Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on March 03, 2015