- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00189124
Dehydroepiandrosterone (DHEA) in Systemic Lupus Erythematosus (SLE) for Coronary Artery Disease (CAD) Prevention
May 17, 2016 updated by: Wendy Marder, University of Michigan
Does DHEA Improve Endothelial Dysfunction and Other Cardiovascular Risk Factors in Premenopausal Women With Systemic Lupus?
The purpose of this study is to evaluate the effect of DHEA on endothelial dysfunction in patients with systemic lupus by measuring:
- changes in brachial artery flow-mediated dilatation (FMD) and
- changes in biomarkers of cardiovascular risk. Patients will be enrolled in a randomized, double-blinded crossover trial of DHEA or placebo for ten weeks, then crossed over to the alternate treatment arm after a six-week washout period.
HYPOTHESIS: Dehydroepiandrosterone (DHEA) administration in premenopausal women with SLE modifies cardiovascular risk by improving vascular endothelial function and other biomarkers associated with cardiovascular heart disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Brachial artery reactivity, by flow mediated dilatation
|
Secondary Outcome Measures
Outcome Measure |
---|
Changes in biomarkers of SLE
|
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Wendy Marder, MD, University of Michigan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2003
Primary Completion (Actual)
December 1, 2005
Study Completion (Actual)
July 1, 2006
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 16, 2005
Study Record Updates
Last Update Posted (Estimate)
May 18, 2016
Last Update Submitted That Met QC Criteria
May 17, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2001-0822
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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