Metformin for the Treatment of Endometrial Hyperplasia
|ClinicalTrials.gov Identifier: NCT01685762|
Recruitment Status : Active, not recruiting
First Posted : September 14, 2012
Last Update Posted : May 5, 2017
|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|
|Study Start Date :||September 2012|
|Primary Completion Date :||December 1, 2015|
|Estimated Study Completion Date :||December 2018|
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.
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|