NCT00004662
Completed
Phase 3
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women With Active Systemic Lupus Erythematosus
National Center for Research Resources (NCRR)0 sites300 target enrollmentMarch 1996
ConditionsSystemic Lupus Erythematosus
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Systemic Lupus Erythematosus
- Sponsor
- National Center for Research Resources (NCRR)
- Enrollment
- 300
- Status
- Completed
- Last Updated
- 20 years ago
Overview
Brief Summary
OBJECTIVES:
I. Evaluate the safety and efficacy of synthetic dehydroepiandrosterone, GL701, in women with active systemic lupus erythematosus.
Detailed Description
PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by participating institution. Patients are randomly assigned to daily oral dehydroepiandrosterone or placebo for 52 weeks. Patients are evaluated every 13 weeks on study and return for a follow-up 6 weeks after completion of therapy. Concurrent therapy with estrogen replacement and stable doses of prednisone, azathioprine, methotrexate (with folate supplementation), hydroxychloroquine, and nonsteroidal anti-inflammatory drugs is allowed. Other investigational medications and immunosuppressants are prohibited.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified
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