Trials / Completed

CompletedNCT00004795

Phase II/III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women With Mild to Moderate Systemic Lupus Erythematosus

Status: Completed
Phase: Phase 2 / Phase 3
Study type: Interventional
Enrollment: 190 (planned)

Sponsor: National Center for Research Resources (NCRR) · NIH
Sex: Female
Age: 18 Years
Healthy volunteers: Not accepted

Summary

OBJECTIVES: I. Evaluate the safety and efficacy of synthetic dehydroepiandrosterone (GL701) in women with prednisone-dependent systemic lupus erythematosus. II. Describe the pharmacokinetics of GL701.

Detailed description

PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution. Patients are randomly assigned to 1 of 2 doses of oral dehydroepiandrosterone or placebo, administered daily for a minimum of 7 months. A prednisone taper is attempted each month in patients with stable or improving disease. Therapy continues until a successful prednisone taper is achieved and sustained for at least 2 months, or until a maximum of 9 months. Patients are followed for 1 year after entry.

Conditions

Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	dehydroepiandrosterone

Timeline

Start date: 1994-08-01
First posted: 2000-02-25
Last updated: 2005-06-24

Source: ClinicalTrials.gov record NCT00004795. Inclusion in this directory is not an endorsement.