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

Phase 2

Completed

• Conditions: Lupus Erythematosus, Systemic; Sjogren's Syndrome

• Registration Number: NCT00391924
• Lead Sponsor: UMC Utrecht

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 syndrome

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 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 Timeline

• Study Start: 2000-05
• Study Completion: 2003-01
• Status Verified: 2006-10
• Study First Submitted: 2006-10-24
• Study First Submitted QC: 2006-10-24
• Last Update Submitted: 2006-10-24
• Study First Posted: 2006-10-25
• Last Update Posted: 2006-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
General fatigue
Depressive mood
Mental well-being
Physical functioning
(all measures at baseline, after 3, 6, and 12 months of intake of study medication, and 6 months after cessation of medication intake)

Secondary Outcome Measures

Name	Time	Method
Fibromyalgia tender points
Erythrocyte sedimentation rate
Hemoglobin
Self-reported pain,
Serum Immunoglobulin-G
Self-reported ocular dryness (in pSS only)
Self-reported oral dryness (in pSS only)
Ocular tear production (in pSS only)
SLE disease activity index (in SLE only)
Bone mineral density (in SLE only)
Dose of glucocorticoids (in SLE only)

Trial Locations

Locations (2)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands