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

University of Michigan

Status and phase: Completed; Phase 3; Phase 2

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: Dehydroepiandrosterone (DHEA)

Study type: Interventional

Funder types: Other

Identifiers

NCT00189124

2001-0822

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind