Metformin for the Treatment of Endometrial Hyperplasia
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.
Endometrial Hyperplasia Without Atypia
|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|
- Response Rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Evaluation of hyperplasia resolution by comparison of pre- and post-treatment endometrial biopsies.
- 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.
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Metformin once daily for 4 weeks (weeks 1-4) and then twice daily for 8 weeks (weeks 5-12).
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).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01685762
|Contact: Mark Bozymskifirstname.lastname@example.org|
|Contact: Donna Rowe, RNemail@example.com|
|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 firstname.lastname@example.org|
|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|
|Principal Investigator:||Victoria Bae-Jump, MD, PhD||University of North Carolina, Chapel Hill|