Effect of Rosiglitazone on Peritoneal Cytokines in Women With Endometriosis

• Status: Withdrawn
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Rosiglitazone

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.