Effect of Rosiglitazone on Peritoneal Cytokines in Women With Endometriosis

NCT00121953 | Withdrawn Phase 2

• 2 other identifiers: 2004-10121K23HD043952-01A2
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Keywords

Endometriosis; Peritoneal fluid; Cytokines; Peroxisome Proliferator-Activated Receptors

Outcome Measures

Primary Outcomes (1)

• Peritoneal fluid cytokine concentrations

Secondary Outcomes (3)

• Cytokine quantification

• Proteomics

• Gene array analyses

Interventions

Rosiglitazone DRUG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

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

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Lebovic DI, Kir M, Casey CL. Peroxisome proliferator-activated receptor-gamma induces regression of endometrial explants in a rat model of endometriosis. Fertil Steril. 2004 Oct;82 Suppl 3:1008-13. doi: 10.1016/j.fertnstert.2004.02.148.

  PMID: 15474065 BACKGROUND

MeSH Terms

Conditions

Endometriosis

Interventions

Rosiglitazone

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dan I. Lebovic, MD, MA

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 18, 2005
• First Posted: July 21, 2005
• Study Start: July 1, 2005
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: October 17, 2012

Record last verified: 2012-10

Locations

US (1)