Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121953
Status:
WITHDRAWN
Last Update Posted:
2012-10-17
First Post:
2005-07-18
Brief Title:
Effect of Rosiglitazone on Peritoneal Cytokines in Women With Endometriosis
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Endometriosis Immunomodulation
Status:
WITHDRAWN
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to the recent meta-analysis about CV adverse effects
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1K23HD043952-01A2 | NIH | None | httpsreporternihgovquickSearch1K23HD043952-01A2 |