Effect of Rosiglitazone on Peritoneal Cytokines in Women With Endometriosis

This study has been withdrawn prior to enrollment.
(Due to the recent meta-analysis about CV adverse effects.)
Sponsor:
Information provided by (Responsible Party):
Dan Lebovic, University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00121953
First received: July 18, 2005
Last updated: October 16, 2012
Last verified: October 2012
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
Official Title: Endometriosis: Immunomodulation

Resource links provided by NLM:


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

Enrollment: 0
Study Start Date: July 2005
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Dan I. Lebovic, MD, MA University of Michigan
  More Information

Additional Information:
Publications:
Responsible Party: Dan Lebovic, Associate Professor, University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00121953     History of Changes
Other Study ID Numbers: 2004-1012, 1K23-HD43952-01A2
Study First Received: July 18, 2005
Last Updated: October 16, 2012
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

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014