drugset / Trial / NCT00543166
Sex Steroids in Sjögren's Syndrome: Effect of Substitution Treatment on Fatigue
Phase 4
Unknown
107 enrolled
University of Helsinki
Göteborg University · collabUppsala University · collab
RandomizedCrossoverTriple-blindTreatment
Summary
Our research contributes to the understanding of some of the basic biology of the salivary glands. The etiology and many of the pathomechanisms of Sjögren's syndrome are unknown. In particular, reasons for the female dominance, late age of onset, fatigue and the prominent involvement of exocrine glands are unknown. We hypothesize, due to the disease characteristics, that the primary target hit by the disease process is the secretory acinar cell and that this cell is particularly damaged in women due to insufficient support, normally provided by dehydroepiandrosterone and its intracrine processing.
Timeline
- Start
- 2003-02
- Primary completion
- —
- Completion
- 2009-12
Publications
- Background Laine M, Virtanen I, Salo T, Konttinen YT. Segment-specific but pathologic laminin isoform profiles in human labial salivary glands of patients with Sjogren's syndrome. Arthritis Rheum. 2004 Dec;50(12):3968-73. doi: 10.1002/art.20730.
- Background Konttinen YT, Tensing EK, Laine M, Porola P, Tornwall J, Hukkanen M. Abnormal distribution of aquaporin-5 in salivary glands in the NOD mouse model for Sjogren's syndrome. J Rheumatol. 2005 Jun;32(6):1071-5.
- Background Valtysdottir ST, Wide L, Hallgren R. Low serum dehydroepiandrosterone sulfate in women with primary Sjogren's syndrome as an isolated sign of impaired HPA axis function. J Rheumatol. 2001 Jun;28(6):1259-65.
- Results Laine M, Porola P, Udby L, Kjeldsen L, Cowland JB, Borregaard N, Hietanen J, Stahle M, Pihakari A, Konttinen YT. Low salivary dehydroepiandrosterone and androgen-regulated cysteine-rich secretory protein 3 levels in Sjogren's syndrome. Arthritis Rheum. 2007 Aug;56(8):2575-84. doi: 10.1002/art.22828.
- Virkki LM, Porola P, Forsblad-d'Elia H, Valtysdottir S, Solovieva SA, Konttinen YT. Dehydroepiandrosterone (DHEA) substitution treatment for severe fatigue in DHEA-deficient patients with primary Sjogren's syndrome. Arthritis Care Res (Hoboken). 2010 Jan 15;62(1):118-24. doi: 10.1002/acr.20022.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dehydroepiandrosterone | Other / unclassified | 50 mg | — |