Phase II/III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women With Mild to Moderate Systemic Lupus Erythematosus
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|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)|
|Estimated Enrollment :||190 participants|
|Study Start Date :||August 1994|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004795
|Study Chair:||Rosalind Ramsey-Goldman||Northwestern University|