The purpose of this study is to compare the effect of pioglitazone versus no drug on soluble profinflammatory markers in peritoneal fluid of women with endometriosis.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Effect of Pioglitazone on Peritoneal Cytokines in Women With Endometriosis|
- Peritoneal cytokine levels [ Time Frame: Within 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||May 2012|
|Estimated Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Pioglitazone study drug
Pioglitazone, 30 mg, by mouth daily for 2 weeks
Other Name: Actos
No Intervention: No drug
"Placebo" like comparitor
The overall goal of this proposal is to assess modulation of immune mechanisms in endometriosis. Endometriosis is a common ailment affecting approximately five million reproductive-aged American women. We will test the efficacy of a novel immunomodulatory drug (peroxisome proliferator activated receptor gamma, PPAR-gamma, agonist), pioglitazone, to reduce peritoneal fluid cytokine concentrations in women with endometriosis compared with the non-treated controls (randomized controlled trial). Based on prior studies done by the investigator highlighting the major role of cytokines and the immune system in the genesis or propagation of endometriosis, these experiments could lead to improved translational treatment strategies and a better understanding of endometriosis. Acting through PPAR-gamma, TZDs inhibit proinflammatory cytokines as well as NF-kB, an important nuclear transcription factor for the production of many cytokines. Accordingly, since human endometrial epithelial and stromal cells contain PPAR-gamma, we felt i would be useful to evaluate the influence of a PPAR-gamma ligand, pioglitazone, on the concentration of specific peritoneal fluid cytokines.
Comparison: After the pre-trial screening, eligible subjects with presumed endometriosis and age 18-45 will be consented and randomly assigned to receive either pioglitazone (30 mg, daily)or no drug for 2 weeks. Peritoneal fluid will be collected at the time of surgery and the volume measured. All patients enrolled in the study will have their surgery during the follicular phase of the cycle in order to minimize differences in volume and cytokine concentration due to the cyclical changes. The primary measure will be the peritoneal fluid concentration comparisons of the two groups assessing six different cytokines.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01184144
|Principal Investigator:||Dan I Lebovic, MD||Univ Wisconsin|