Use of Rosiglitazone in the Treatment of Endometriosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00115661
Recruitment Status : Terminated (Due to the meta-analysis about CV adverse effects of rosiglitazone.)
First Posted : June 24, 2005
Last Update Posted : October 17, 2012
Berlex Foundation
Information provided by (Responsible Party):
Dan Lebovic, University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
Endometriosis Drug: Rosiglitazone Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Endometriosis Pain With Rosiglitazone: A Prospective Phase 2 Clinical Trial
Study Start Date : July 2005
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis
U.S. FDA Resources

Primary Outcome Measures :
  1. 28-day visual analog scale diary (one for each day for 4 weeks) at baseline and at conclusion of 6 months

Secondary Outcome Measures :
  1. Short-Form McGill Pain Questionnaire at study entry and at 3 and 6 months
  2. Physical component summary score of the SF-36 at baseline and at 3 and 6 months
  3. Cytokine quantification
  4. Proteomics
  5. Gene array analyses

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00115661

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
Principal Investigator: Dan I Lebovic, MD, MA University of Michigan

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dan Lebovic, Associate Professor, University of Wisconsin, Madison Identifier: NCT00115661     History of Changes
Other Study ID Numbers: 2004-1013
1K23HD043952-01A2 ( U.S. NIH Grant/Contract )
First Posted: June 24, 2005    Key Record Dates
Last Update Posted: October 17, 2012
Last Verified: October 2012

Keywords provided by Dan Lebovic, University of Wisconsin, Madison:
Peroxisome Proliferator-Activated Receptors
treatment of endometriosis

Additional relevant MeSH terms:
Genital Diseases, Female
Hypoglycemic Agents
Physiological Effects of Drugs