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Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women with Active Systemic Lupus Erythematosus Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women with Active Systemic Lupus Erythematosus conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women with Active Systemic Lupus Erythematosus Clinical research trials and Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women with Active Systemic Lupus Erythematosus health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women with Active Systemic Lupus Erythematosus. Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women with Active Systemic Lupus Erythematosus Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women with Active Systemic Lupus Erythematosus clinical trial. Human subjects frequently get the finest healthcare available for their Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women with Active Systemic Lupus Erythematosus condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women with Active Systemic Lupus Erythematosus  Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women with Active Systemic Lupus Erythematosus
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women with Active Systemic Lupus Erythematosus
For Condition: Systemic Lupus Erythematosus
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , Northwestern University
Synopsis: OBJECTIVES: I. Evaluate the safety and efficacy of synthetic dehydroepiandrosterone, GL701, in women with active systemic lupus erythematosus.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: 18 Years/
Genders: Female
Protocol Entry Criteria: 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
Total Enrollment: 300
Location and Contact Information:
Overall Study Official:
RosalindRamsey-Goldman, Study Chair, Northwestern University
Additional Information:
Study ID Numbers: 199/11918; NU-584
Study Start Date: March 1996
Record last reviewed: December 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004662
Other Systemic Lupus Erythematosus Studies:
1. Randomized Study of Oral Contraceptives or Hormone Replacement Therapy in Women With Systemic Lupus Erythematosus
2. Genetic Studies of Lupus
3. Epidemiologic Study of Reproductive Outcome in Women with Systemic Lupus Erythematosus
4. The Research Registry for Neonatal Lupus
5. Phase II/III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women with Mild to Moderate Systemic Lupus Erythematosus
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Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women with Active Systemic Lupus Erythematosus
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