Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00004665 |
Date of registration:
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24/02/2000 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Phase II Study of Long-Term Dehydroepiandrosterone for Systemic Lupus Erythematosus
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Scientific title:
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Date of first enrolment:
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June 1995 |
Target sample size:
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20 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT00004665 |
Study type:
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Interventional |
Study design:
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Primary Purpose: Treatment
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Phase:
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Phase 2
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Contacts
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Name:
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Rosalind Ramsey-Goldman |
Address:
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Telephone:
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Email:
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Affiliation:
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Northwestern University |
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Key inclusion & exclusion criteria
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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 Prior completion of dehydroepiandrosterone (DHEA) study required No prior
participation in double-blind 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 immunosuppressants, including: Adrenocorticotropin hormone
Androgens Cyclophosphamide Azathioprine Intravenous immune globulin At least 1 month since
change in dose of nonsteroidal anti-inflammatory drugs or hydroxychloroquine --Patient
Characteristics-- Age: 18 and over Sex: Female only Performance status: Not specified
Other: No hypersensitivity to DHEA or inactive ingredient in GL701 formulation, i.e.,
cornstarch, lactose, or 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
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Health Condition(s) or Problem(s) studied
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Systemic Lupus Erythematosus
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Intervention(s)
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Drug: dehydroepiandrosterone
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Secondary ID(s)
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NU-552
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199/11935
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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