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

NCT00543166 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2007-11-05

No results posted yet for this study

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.

Conditions

  • Sjogren's Syndrome

Interventions

DRUG

dehydroepiandrosterone

50 mg of dehydroepiandrosterone in the morning for 4 months in the treatment group.

Sponsors & Collaborators

  • Göteborg University

    collaborator OTHER
  • Uppsala University

    collaborator OTHER
  • University of Helsinki

    lead OTHER

Principal Investigators

  • Yrjö Konttinen, MD, PhD · Helsinki University Central Hospital, Helsinki, Finland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-02-28
Completion
2009-12-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00543166 on ClinicalTrials.gov