NCT00004795
Completed
Phase 2
Phase II/III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women With Mild to Moderate Systemic Lupus Erythematosus
National Center for Research Resources (NCRR)0 sites190 target enrollmentAugust 1994
ConditionsSystemic Lupus Erythematosus
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Systemic Lupus Erythematosus
- Sponsor
- National Center for Research Resources (NCRR)
- Enrollment
- 190
- Status
- Completed
- Last Updated
- 20 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified
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