Trial | NCT00391924  Report issue

Title

Dehydroepiandrosterone Administration in Women With Systemic Lupus Erythematosus or Primary Sjögren's Syndrome
Fatigue and General Well-Being in Patients With Systemic Lupus Erythematosus or Primary Sjögren's Syndrome: Effects of Dehydroepiandrosterone Administration

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    120
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
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 studies suggested that the administration of dehydroepiandrosterone (DHEA) may improve such complaints. The aim of our randomized double-blind placebo-controlled study is to examine the effect of daily oral 200 mg DHEA on fatigue, well-being, and functioning in women with SLE or pSS.
Study Started
May 31
2000
Study Completion
Jan 31
2003
Last Update
Oct 25
2006
Estimate

Drug 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
No Results Posted