Effect of Rosiglitazone on Peritoneal Cytokines in Women With Endometriosis - Full Text View

Sponsored by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00121953

Purpose

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.

Condition	Intervention	Phase
Endometriosis	Drug: Rosiglitazone	Phase II Phase III

MedlinePlus related topics: Endometriosis

Drug Information available for: Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Endometriosis: Immunomodulation

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:

Peritoneal fluid cytokine concentrations

Secondary Outcome Measures:

Cytokine quantification
Proteomics
Gene array analyses

Estimated Enrollment:	140
Study Start Date:	July 2005
Estimated Study Completion Date:	January 2010

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.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Healthy women ages 18 - 45 years.
Regular menstrual cycles (24-35 days).
Pelvic pain ≥3 months
Negative pregnancy test
Non-lactating
No prior (<3 months) use of hormonal therapy (<6 mos for depoprovera users)
No history of liver disease
Consent to participate in the study
Endometriosis diagnosed from surgical specimen by routine hematoxylin and eosin staining and histological evaluation (within the past 4 years)

Exclusion Criteria:

Major psychiatric conditions or the abuse of alcohol or drugs which would make it difficult for the subject to complete study procedures.
Active or prior infection with hepatitis, human immunodeficiency virus (HIV) infection, or history of high-risk activities (e.g., intravenous [IV] drug abuse) which would increase risk to laboratory personnel. Of note, no testing for hepatitis or HIV will be performed as part of this study and all tissues will be handled and discarded as if they were potentially infected.
Patients with liver dysfunction (elevated liver enzymes >2 times upper limit of normal).
Presence of pre-existing malignancy, including carcinoma of the breast or uterus.
Women with other causes of chronic pelvic pain including infectious, gastrointestinal, musculoskeletal, neurologic or psychiatric.
Elevated white blood cell (WBC) count.
NYHA functional class I-IV heart failure.
Diabetes mellitus.
Known pregnancy or positive pregnancy test.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00121953

Locations

United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Principal Investigator:

Dan I. Lebovic, MD, MA

University of Michigan

More Information

University of Michigan Endometriosis Center This link exits the ClinicalTrials.gov site

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.

Study ID Numbers:	2004-1012, 1K23-HD43952-01A2
Study First Received:	July 18, 2005
Last Updated:	June 22, 2007
ClinicalTrials.gov Identifier:	NCT00121953
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Endometriosis
Peritoneal fluid
Cytokines
Peroxisome Proliferator-Activated Receptors

Study placed in the following topic categories:

Genital Diseases, Female
Endometriosis
Rosiglitazone

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009