- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00115661
Use of Rosiglitazone in the Treatment of Endometriosis
Treatment of Endometriosis Pain With Rosiglitazone: A Prospective Phase 2 Clinical Trial
Study Overview
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
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan Health System
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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28-day visual analog scale diary (one for each day for 4 weeks) at baseline and at conclusion of 6 months
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Secondary Outcome Measures
Outcome Measure |
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Cytokine quantification
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Proteomics
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Gene array analyses
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Short-Form McGill Pain Questionnaire at study entry and at 3 and 6 months
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Physical component summary score of the SF-36 at baseline and at 3 and 6 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Dan I Lebovic, MD, MA, University of Michigan
Publications and helpful links
General 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. doi: 10.1016/j.fertnstert.2004.02.148.
- Moravek MB, Ward EA, Lebovic DI. Thiazolidinediones as therapy for endometriosis: a case series. Gynecol Obstet Invest. 2009;68(3):167-70. doi: 10.1159/000230713. Epub 2009 Jul 30.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2004-1013
- 1K23HD043952-01A2 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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