Sex Steroids in Sjögren's Syndrome: Effect of Substitution Treatment on Fatigue

• Status: Unknown status
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Helsinki University; University of Helsinki
• Collaborators: Göteborg University; Uppsala University
• Treatments: Dehydroepiandrosterone

Criteria

Inclusion Criteria:

1. Primary SS according to the American-European consensus criteria

2. General Fatigue ≥14 calculated from MFI-20 (Multiple fatigue inventory-20 questionnaire; the value was based on a pilot study of 239 members of the Finnish SS patient association)

3. subnormal serum S-DHEAS values (the reference values were calculated based on a pilot study of 81 healthy women and 57 healthy men).

Exclusion Criteria:

1. Age <18 years or >80 years

2. prisoner

3. individuals not able to give their informed consent

4. history of breast cancer

5. history of uterus cancer

6. history of prostatic cancer

7. history of stroke or prothrombotic coagulation disorders

8. pregnant or lactating women

9. fertile patients without adequate prevention

10. difficult acne

11. a significant liver disease

12. patients with changes in their systemic medication taken for SS during the previous three months 13) patients taking more than 10 mg prednisolone per day