Metformin for the Treatment of Endometrial Hyperplasia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01685762|
Recruitment Status : Completed
First Posted : September 14, 2012
Last Update Posted : January 18, 2019
|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)|
|Official Title:||Metformin for the Treatment of Endometrial Hyperplasia|
|Actual Study Start Date :||January 10, 2013|
|Actual Primary Completion Date :||December 1, 2015|
|Actual Study Completion Date :||December 1, 2015|
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).
- 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.
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|