Dehydroepiandrosterone Administration in Women With Systemic Lupus Erythematosus or Primary Sjögren's Syndrome

• Status: Completed
• Trial end date: 2003-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of the study is to examine whether dehydroepiandrosterone (DHEA) administration improves fatigue and general well-being in patients with systemic lupus erythematosus or primary Sjögren's syndrome

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UMC Utrecht
• Collaborators: Dutch Arthritis Association; University Medical Center Groningen
• Treatments: Dehydroepiandrosterone

Criteria

Inclusion Criteria:

• pSS with a focus score >= 1 on minor salivary gland biopsy and fulfilling European classification criteria (Ann Rheum Dis 1996;55:116-21)

• SLE according to ACR classification criteria (Arthritis Rheum 1982;25:1271-7)

• Willingness to apply effective contraception (premenopausal women)

• Written informed consent.

Exclusion Criteria:

• Pregnancy

• Pregnancy wish

• Serum creatinine > 150 µmol/L

• Glucocorticoid use at a daily dose > 10 mg prednisone (or equivalent)

• Cyclophosphamide treatment in the preceding year

• Hyper- or hypothyroidism

• History of malignancy within the previous 5 years with exception of squamous or basal cell carcinoma of the skin