Status:
WITHDRAWN
Effect of Rosiglitazone on Peritoneal Cytokines in Women With Endometriosis
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Endometriosis
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00121953
Start Date
July 1 2005
End Date
May 1 2008
Last Update
October 17 2012
Active Locations (1)
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1
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109