Use of Rosiglitazone in the Treatment of Endometriosis

This study has been terminated.

( Due to the meta-analysis about CV adverse effects of rosiglitazone. )

First Received on June 23, 2005. Last Updated on August 31, 2010 History of Changes

Sponsor:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator:	Berlex Foundation
Information provided by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00115661

Purpose

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.

Condition	Intervention	Phase
Endometriosis	Drug: Rosiglitazone	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Treatment of Endometriosis Pain With Rosiglitazone: A Prospective Phase 2 Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Endometriosis

Drug Information available for: Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	25
Study Start Date:	July 2005
Estimated Study Completion Date:	January 2010

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.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00115661

Locations

United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

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

Berlex Foundation

Investigators

Principal Investigator:

Dan I Lebovic, MD, MA

University of Michigan Health System

More Information

Additional Information:

University of Michigan Endometriosis Center This link exits the ClinicalTrials.gov site

Publications:

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Moravek MB, Ward EA, Lebovic DI. Thiazolidinediones as therapy for endometriosis: a case series. Gynecol Obstet Invest. 2009;68(3):167-70. Epub 2009 Jul 30.

ClinicalTrials.gov Identifier:	NCT00115661 History of Changes
Other Study ID Numbers:	2004-1013, 1K23-HD43952-01A2
Study First Received:	June 23, 2005
Last Updated:	August 31, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Peroxisome Proliferator-Activated Receptors
treatment of endometriosis

Additional relevant MeSH terms:

Endometriosis
Genital Diseases, Female
Rosiglitazone

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012