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

Systemic Lupus Erythematosus Clinical Trial

Official title:

Does DHEA Improve Endothelial Dysfunction and Other Cardiovascular Risk Factors in Premenopausal Women With Systemic Lupus?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00189124
• Other study ID #: 2001-0822
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 13, 2005
• Last updated: May 17, 2016
• Start date: September 2003
• Est. completion date: July 2006

Study information

• Verified date: May 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: July 2006
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• Dehydroepiandrosterone (DHEA)

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Arthritis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brachial artery reactivity, by flow mediated dilatation
Secondary	Changes in biomarkers of SLE
Secondary	Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score