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Trial record 32 of 235 for:    PRASTERONE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004795
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
Northwestern University
Information provided by:
Office of Rare Diseases (ORD)

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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: dehydroepiandrosterone Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 190 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Study Start Date : August 1994

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
Drug Information available for: Prasterone

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


--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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004795

Sponsors and Collaborators
National Center for Research Resources (NCRR)
Northwestern University
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Study Chair: Rosalind Ramsey-Goldman Northwestern University

Layout table for additonal information Identifier: NCT00004795     History of Changes
Other Study ID Numbers: 199/11930
First Posted: February 25, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: December 2001
Keywords provided by Office of Rare Diseases (ORD):
arthritis & connective tissue diseases
immunologic disorders and infectious disorders
rare disease
systemic lupus erythematosus
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs