Use of Rosiglitazone in the Treatment of Endometriosis

Phase 2

Terminated

• Conditions: Endometriosis

• Registration Number: NCT00115661
• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Brief Summary

The purpose of this study is to perform a pilot study on the efficacy of rosiglitazone in reducing pelvic pain in early stage endometriosis patients.

Detailed Description

There is no current pain control in women with minimal-mild endometriosis that concomitantly allows them the chance to conceive. Women between the ages of 18 and 45 years with minimal to mild endometriosis and pelvic pain of greater than three months duration, will be enrolled into a 6-month prospective phase 2 clinical trial.

Comparison: Following enrollment, one week after the last menstrual period, eligible participants will be randomized to a 6-month treatment of rosiglitazone 4 mg/day. Efficacy comparisons will be made utilizing visual analog scale diaries, Short-Form McGill Pain Questionnaires and physical component summary scores of the SF-36. Secondary measures will include cytokine quantification, proteomics, gene array analyses and serious adverse effects.

Study Timeline

• Study First Submitted: 2005-06-23
• Study First Submitted QC: 2005-06-23
• Study First Posted: 2005-06-24
• Study Start: 2005-07
• Primary Completion: 2006-05
• Study Completion: 2006-05
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-16
• Last Update Posted: 2012-10-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 25

Inclusion Criteria

• Healthy women ages 18 - 45 years.
• Regular menstrual cycles (24-35 days).
• Pelvic pain ≥ 3 months with cyclical component.
• Negative pregnancy test and must use nonhormonal contraception.
• Non-lactating.
• 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., 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 the 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 WBC.
• NYHA functional class I-IV heart failure.
• Diabetics.
• Known pregnancy or positive pregnancy test.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
28-day visual analog scale diary (one for each day for 4 weeks) at baseline and at conclusion of 6 months

Secondary Outcome Measures

Name	Time	Method
Short-Form McGill Pain Questionnaire at study entry and at 3 and 6 months
Physical component summary score of the SF-36 at baseline and at 3 and 6 months
Cytokine quantification
Proteomics
Gene array analyses

Trial Locations

Locations (1)

University of Michigan Health System; 🇺🇸 Ann Arbor, Michigan, United States