drugset / Trial / NCT00189124

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

NCT00189124

Phase 2/3 Completed 13 enrolled University of Michigan Arthritis Foundation · collab
RandomizedCrossoverTriple-blindTreatment

Summary

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.

Timeline

Start
2003-09
Primary completion
2005-12
Completion
2006-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Dehydroepiandrosterone Other / unclassified