Dehydroepiandrosterone (DHEA) in Systemic Lupus Erythematosus (SLE) for Coronary Artery Disease (CAD) Prevention

Completed · Phase 2/Phase 3

Conditions studied: Systemic Lupus Erythematosus

In brief

The purpose of this study is to evaluate the effect of DHEA on endothelial dysfunction in patients with systemic lupus by measuring: 1. changes in brachial artery flow-mediated dilatation (FMD) and 2. 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.

Key facts

Study ID

NCT00189124

Run by

University of Michigan

People needed

13

Starts

2003-09-01

Expected to finish

2006-07-01

Last updated by the study team

2016-05-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female
• Member of the Michigan Lupus Cohort
• Meet the American College of Rheumatology (ACR) criteria for SLE
• Premenopausal

You may not qualify if…

• Smoker
• Diabetic
• Prednisone dose > 10 mg

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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