Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women With Active Systemic Lupus Erythematosus

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Systemic lupus erythematosus by 1982 American College of Rheumatology criteria Diagnosed for at least 6 months Systemic Lupus Activity Measure score at least 7 Points for erythrocyte sedimentation rate excluded SLEDAI score of greater than 2 at both screening and qualifying visits --Prior/Concurrent Therapy-- No prior participation in any dehydroepiandrosterone (DHEA) study No investigational agent within the longer of 30 days or 10 half-lives of the agent Prednisone (or equivalent) dose 0 to 10 mg/day Unchanged for at least 6 weeks prior to entry At least 3 months since immunosuppressants other than azathioprine and methotrexate, including: * DHEA * Adrenocorticotropin hormone * Androgens * Cyclophosphamide * Cyclosporine * Immune globulin At least 6 weeks since change in azathioprine, methotrexate, or hydroxychloroquine --Patient Characteristics-- Renal: No requirement for hemodialysis Cardiovascular: No serious abnormality on electrocardiogram Other: * No hypersensitivity to DHEA or inactive ingredients in GL701 formulation, i.e., cornstarch, lactose, or magnesium stearate * No history of breast cancer or reproductive tract malignancy * Cervical carcinoma eligible if surgically cured, i.e., no evidence of disease for 5 years * No condition that would prevent compliance or follow-up, e.g.: Alcoholism Drug addiction Acute withdrawal from chemical dependency * Psychiatric disease * No pregnant or nursing women * Negative pregnancy test required of fertile women * Reliable contraception required of fertile women * No estrogen-containing oral contraceptives on study * At least 3 weeks since estrogen-containing oral contraceptives