Use of Rosiglitazone in the Treatment of Endometriosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Treatment of Endometriosis Pain With Rosiglitazone: A Prospective Phase 2 Clinical Trial

Conditions
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Endometriosis

Intervention / Treatment
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* Drug: Rosiglitazone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rosiglitazone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day visual analog scale diary (one for each day for 4 weeks) at baseline and at conclusion of 6 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peroxisome Proliferator-Activated Receptors, treatment of endometriosis