Status:
COMPLETED
Dehydroepiandrosterone Administration in Women With Systemic Lupus Erythematosus or Primary Sjögren's Syndrome
Lead Sponsor:
UMC Utrecht
Collaborating Sponsors:
University Medical Center Groningen
Dutch Arthritis Association
Conditions:
Lupus Erythematosus, Systemic
Sjogren's Syndrome
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 s...
Detailed Description
Fatigue and reduced general well-being are frequent complaints in patients with the chronic autoimmune disorder systemic lupus erythematosus (SLE) or primary Sjögren's syndrome (pSS). Uncontrolled stu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2000
Trial Type :
INTERVENTIONAL
End Date :
January 1 2003
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00391924
Start Date
May 1 2000
End Date
January 1 2003
Last Update
October 25 2006
Active Locations (2)
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1
University Medical Center Groningen
Groningen, Netherlands, 9700RB
2
University Medical Center Utrecht
Utrecht, Netherlands, 3508GA