Phase II/III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women With Mild to Moderate Systemic Lupus Erythematosus

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00004795
• Date of registration: 24/02/2000
• Prospective Registration: No
• Primary sponsor: National Center for Research Resources (NCRR)
• Public title: Phase II/III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women With Mild to Moderate Systemic Lupus Erythematosus
• Date of first enrolment: August 1994
• Target sample size: 190
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00004795
• Study type: Interventional
• Study design: Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 2/Phase 3

Contacts

• Name: Rosalind Ramsey-Goldman
• Affiliation: Northwestern University

Key inclusion & exclusion criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Systemic lupus erythematosus by American College of
Rheumatology criteria Mild to moderate disease characterized as follows: Prednisone dose
(or equivalent) 10 to 30 mg/day No daily dose 1 mg/kg or greater No alternate-day regimen
Failed prednisone taper in last 12 months and dose stable for at least 6 weeks prior to
entry OR No attempt to taper in last 12 months and dose stable for at least 3 months prior
to entry No prior participation in double-blind dehydroepiandrosterone (DHEA) study at
Stanford University --Prior/Concurrent Therapy-- No concurrent immunosuppressants No
concurrent participation in other clinical studies No investigational agents within the
longer of 30 days or 10 half lives of the agent At least 3 months since the following:
Adrenocorticotropin hormone Androgens Cyclophosphamide Azathioprine Intravenous immune
globulin Other immunosuppressants At least 1 month since any change in dose of concurrent
nonsteroidal anti- inflammatory drugs or hydroxychloroquine --Patient Characteristics-- No
hypersensitivity to DHEA or inactive ingredient in DHEA, i.e.: Cornstarch Lactose
Magnesium stearate No condition that would prevent adequate compliance with study No
history of breast cancer or reproductive tract malignancy Negative pregnancy test required
within 2 weeks prior to entry Reliable contraception required of fertile women No
estrogen-containing oral contraceptive



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: dehydroepiandrosterone

Secondary ID(s)

199/11930

NU-517

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Northwestern University