MedTrace Logo

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

NCT00189124 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2016-05-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Dehydroepiandrosterone (DHEA)

Sponsors & Collaborators

Principal Investigators

  • Wendy Marder, MD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2005-12-31
Completion
2006-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00189124 on ClinicalTrials.gov