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Effect of Rosiglitazone on Peritoneal Cytokines in Women With Endometriosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00121953
Recruitment Status : Withdrawn (Due to the recent meta-analysis about CV adverse effects.)
First Posted : July 21, 2005
Last Update Posted : October 17, 2012
Information provided by (Responsible Party):
Dan Lebovic, University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
Endometriosis Drug: Rosiglitazone Phase 2 Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Diagnostic
Official Title: Endometriosis: Immunomodulation
Study Start Date : July 2005
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Primary Outcome Measures :
  1. Peritoneal fluid cytokine concentrations

Secondary Outcome Measures :
  1. Cytokine quantification
  2. Proteomics
  3. Gene array analyses

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00121953

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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)
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Principal Investigator: Dan I. Lebovic, MD, MA University of Michigan

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Responsible Party: Dan Lebovic, Associate Professor, University of Wisconsin, Madison Identifier: NCT00121953    
Other Study ID Numbers: 2004-1012
1K23HD043952-01A2 ( U.S. NIH Grant/Contract )
First Posted: July 21, 2005    Key Record Dates
Last Update Posted: October 17, 2012
Last Verified: October 2012
Keywords provided by Dan Lebovic, University of Wisconsin, Madison:
Peritoneal fluid
Peroxisome Proliferator-Activated Receptors
Additional relevant MeSH terms:
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Genital Diseases, Female
Hypoglycemic Agents
Physiological Effects of Drugs