Phase II/III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women With Mild to Moderate Systemic Lupus Erythematosus
|ClinicalTrials.gov Identifier: NCT00004795|
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
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.
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus||Drug: dehydroepiandrosterone||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||190 participants|
|Study Start Date :||August 1994|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004795
|Study Chair:||Rosalind Ramsey-Goldman||Northwestern University|