Effect of Rosiglitazone on Peritoneal Cytokines in Women With Endometriosis

Withdrawn before enrolling · Phase 2/Phase 3

Conditions studied: Endometriosis

In brief

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.

Key facts

Study ID

NCT00121953

Run by

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

People needed

0

Starts

2005-07-01

Expected to finish

2008-05-01

Last updated by the study team

2012-10-17

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• University of Michigan Health System — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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