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

NCT00004662 | Completed Phase 3

• 2 other identifiers: 199/11918NU-584
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

OBJECTIVES: I. Evaluate the safety and efficacy of synthetic dehydroepiandrosterone, GL701, in women with active systemic lupus erythematosus.

Conditions

Systemic Lupus Erythematosus

Keywords

arthritis & connective tissue diseases; immunologic disorders and infectious disorders; rare disease; systemic lupus erythematosus

Interventions

dehydroepiandrosterone DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Center for Research Resources (NCRR): lead
• Northwestern University: collaborator

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Arthritis; Connective Tissue Diseases; Immune System Diseases; Communicable Diseases; Rare Diseases

Interventions

Dehydroepiandrosterone

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Ketosteroids; Ketosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Officials

• Rosalind Ramsey-Goldman

  Northwestern University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 24, 2000
• First Posted: February 25, 2000
• Study Start: March 1, 1996
• Last Updated: June 24, 2005

Record last verified: 2001-12