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Sponsors and Collaborators: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Berlex Foundation |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00115661 |
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 |
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Endometriosis |
Drug: Rosiglitazone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Treatment of Endometriosis Pain With Rosiglitazone: A Prospective Phase 2 Clinical Trial |
Estimated Enrollment: | 25 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | January 2010 |
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.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Michigan | |
University of Michigan Health System | |
Ann Arbor, Michigan, United States, 48109 |
Principal Investigator: | Dan I Lebovic, MD, MA | University of Michigan Health System |
Study ID Numbers: | 2004-1013, 1K23-HD43952-01A2 |
Study First Received: | June 23, 2005 |
Last Updated: | June 22, 2007 |
ClinicalTrials.gov Identifier: | NCT00115661 |
Health Authority: | United States: Food and Drug Administration |
Peroxisome Proliferator-Activated Receptors treatment of endometriosis |
Genital Diseases, Female Endometriosis Pain Rosiglitazone |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |