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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00391924
• Date of registration: 24/10/2006
• Prospective Registration: No
• Primary sponsor: UMC Utrecht
• Public title: Dehydroepiandrosterone Administration in Women With Systemic Lupus Erythematosus or Primary Sjögren's Syndrome
• Scientific title: Fatigue and General Well-Being in Patients With Systemic Lupus Erythematosus or Primary Sjögren's Syndrome: Effects of Dehydroepiandrosterone Administration
• Date of first enrolment: May 2000
• Target sample size: 120
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00391924
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Netherlands

Contacts

• Name: Ronald HW Derksen, MD,PhD
• Affiliation: UMC Utrecht

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Lupus Erythematosus, Systemic

Sjogren's Syndrome

Intervention(s)

Drug: Dehydroepiandrosterone

Primary Outcome(s)

Depressive mood

General fatigue

Mental well-being

(all measures at baseline, after 3, 6, and 12 months of intake of study medication, and 6 months after cessation of medication intake)

Physical functioning

Secondary Outcome(s)

Ocular tear production (in pSS only)

Self-reported pain,

SLE disease activity index (in SLE only)

Hemoglobin

Bone mineral density (in SLE only)

Fibromyalgia tender points

Self-reported ocular dryness (in pSS only)

Serum Immunoglobulin-G

Self-reported oral dryness (in pSS only)

Dose of glucocorticoids (in SLE only)

Erythrocyte sedimentation rate

Secondary ID(s)

NR 98-2-301

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Dutch Arthritis Association

University Medical Centre Groningen