Use of Rosiglitazone in the Treatment of Endometriosis
The purpose of this study is to perform a pilot study on the efficacy of rosiglitazone in reducing pelvic pain in early stage endometriosis patients.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of Endometriosis Pain With Rosiglitazone: A Prospective Phase 2 Clinical Trial|
- 28-day visual analog scale diary (one for each day for 4 weeks) at baseline and at conclusion of 6 months
- Short-Form McGill Pain Questionnaire at study entry and at 3 and 6 months
- Physical component summary score of the SF-36 at baseline and at 3 and 6 months
- Cytokine quantification
- Gene array analyses
|Study Start Date:||July 2005|
|Study Completion Date:||May 2006|
|Primary Completion Date:||May 2006 (Final data collection date for primary outcome measure)|
There is no current pain control in women with minimal-mild endometriosis that concomitantly allows them the chance to conceive. Women between the ages of 18 and 45 years with minimal to mild endometriosis and pelvic pain of greater than three months duration, will be enrolled into a 6-month prospective phase 2 clinical trial.
Comparison: Following enrollment, one week after the last menstrual period, eligible participants will be randomized to a 6-month treatment of rosiglitazone 4 mg/day. Efficacy comparisons will be made utilizing visual analog scale diaries, Short-Form McGill Pain Questionnaires and physical component summary scores of the SF-36. Secondary measures will include cytokine quantification, proteomics, gene array analyses and serious adverse effects.
|United States, Michigan|
|University of Michigan Health System|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Dan I Lebovic, MD, MA||University of Michigan Health System|