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NCT00189124 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by University of Michigan.

Completed
Registry status
Phase 2
Development phase
13
Enrollment target

NCT00189124 is a Phase 2 study that has completed, run by University of Michigan. The registered enrollment target is 13 participants.

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The verdict

NCT00189124, a Phase 2 study, has completed, sponsored by University of Michigan.

COMPLETED
Registry status
Phase 2
Development phase
13 participants
Enrollment target

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.

Interventions

  • DRUG Dehydroepiandrosterone (DHEA)

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2003-09
Est. Completion 2006-07
Phase Phase 2

Sponsor

University of Michigan

1,327 total trials

What the Registry Record Tells You About NCT00189124

The ClinicalTrials.gov registry entry for NCT00189124 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Dehydroepiandrosterone (DHEA) is the first listed.

NCT00189124 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00189124 about?

NCT00189124 is a clinical study titled "Dehydroepiandrosterone (DHEA) in Systemic Lupus Erythematosus (SLE) for Coronary Artery Disease (CAD) Prevention". 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-bl...

What is the current status of trial NCT00189124?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2003-09. Estimated completion is 2006-07.

What interventions are being tested in trial NCT00189124?

The interventions under investigation include: Dehydroepiandrosterone (DHEA) (DRUG).

Who is sponsoring clinical trial NCT00189124?

This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.