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

UMC Utrecht

Status and phase

Completed

Phase 2

Conditions

Lupus Erythematosus, Systemic

Sjogren's Syndrome

Treatments

Drug: Dehydroepiandrosterone

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00391924

NR 98-2-301

Details and patient eligibility

About

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

Full 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.

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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