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Tracking Information | |||||
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First Received Date † | July 18, 2005 | ||||
Last Updated Date | June 22, 2007 | ||||
Start Date † | July 2005 | ||||
Current Primary Outcome Measures † |
Peritoneal fluid cytokine concentrations | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00121953 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |||||
Brief Title † | Effect of Rosiglitazone on Peritoneal Cytokines in Women With Endometriosis | ||||
Official Title † | Endometriosis: Immunomodulation | ||||
Brief Summary | The purpose of this study is to compare the effect of rosiglitazone versus placebo on soluble proinflammatory markers in peritoneal fluid of women with endometriosis. |
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Detailed Description | 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), rosiglitazone, to reduce peritoneal fluid cytokine concentrations in women with endometriosis compared with placebo 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 it would be useful to evaluate the influence of a PPAR-gamma ligand, rosiglitazone, 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 placebo (control) or rosiglitazone, Avandia®, 4 mg daily 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: interleukin-1 beta, RANTES, tumor necrosis factor-alpha and vascular endothelial growth factor. |
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Study Phase | Phase II, Phase III | ||||
Study Type † | Interventional | ||||
Study Design † | Diagnostic, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study | ||||
Condition † | Endometriosis | ||||
Intervention † | Drug: Rosiglitazone | ||||
Study Arms / Comparison Groups | |||||
Publications * | Lebovic DI, Kir M, Casey CL. Peroxisome proliferator-activated receptor-gamma induces regression of endometrial explants in a rat model of endometriosis. Fertil Steril. 2004 Oct;82 Suppl 3:1008-13. | ||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Suspended | ||||
Enrollment † | 140 | ||||
Estimated Completion Date | January 2010 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||
Ages | 18 Years to 45 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00121953 | ||||
Responsible Party | |||||
Secondary IDs †† | 1K23-HD43952-01A2 | ||||
Study Sponsor † | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||
Verification Date | September 2006 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |