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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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30 May 2016 |
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Main ID: |
NCT00189124 |
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Date of registration:
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13/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Dehydroepiandrosterone (DHEA) in Systemic Lupus Erythematosus (SLE) for Coronary Artery Disease (CAD) Prevention
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Scientific title:
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Does DHEA Improve Endothelial Dysfunction and Other Cardiovascular Risk Factors in Premenopausal Women With Systemic Lupus? |
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Date of first enrolment:
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September 2003 |
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Target sample size:
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13 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00189124 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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United States
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Contacts
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Name:
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Wendy Marder, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Michigan |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Female
- Member of the Michigan Lupus Cohort
- Meet the American College of Rheumatology (ACR) criteria for SLE
- Premenopausal
Exclusion Criteria:
- Smoker
- Diabetic
- Prednisone dose > 10 mg
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Systemic Lupus Erythematosus
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Intervention(s)
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Drug: Dehydroepiandrosterone (DHEA)
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Primary Outcome(s)
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Brachial artery reactivity, by flow mediated dilatation
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Secondary Outcome(s)
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Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score
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Changes in biomarkers of SLE
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Secondary ID(s)
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2001-0822
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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