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Status unknownNCT00543166Updated Nov 4, 2007

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

A Phase 4 interventional study of dehydroepiandrosterone in Sjogren's Syndrome, sponsored by University of Helsinki. Status unknown at 1 site in Finland. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2007-11-04.

Sponsored by University of Helsinki · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2007), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
107
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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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.

Read the detailed description

We hypothesize, due to the Sjögren's syndrome (SS) disease characteristics, that the primary target hit by the disease process is the secretory acinar cell and that this cell is particularly in women damaged due to insufficient support, normally provided by dehydroepiandrosterone and its intracrine processing. Dehydroepiandrosterone deficiency at the time of adrenopause seems to us as the more likely endocrine trigger than estrogen deficiency caused by menopause as androgens in general are considered to be protective against autoimmunity and estrogens to favor it. Acinar cell is normally responsible for the production of primary saliva. Acinar cell damage can lead to acinar cell apoptosis and loss. Normally this is compensated by division of the acinar cells in situ or, according to recent reports, perhaps rather by division and subsequent migration of one of the daughter cells into the acinar space and transdifferentiation of this intercalated ductal cell progenitor into mature acinar cell. In SS this remodeling seems to be impaired, perhaps for the same reason, which also leads to primary acinar cell damage. According to this hypothesis, the primary changes occur in the salivary glands and more specifically in the acinar cells, whereas immune activation and autoimmunity are secondarily activated against abnormally damaged acinar cells so that individuals with the "right" genetic background also produce SS-A and SS-B antibodies. The cause of the acinar cell damage may not be a direct, damaging stimulus, e.g. virus infection or irradiation damage, but rather lack of a supporting anabolic stimulus and inadequate maintenance of the acinar cell health leading to cytopathic acinar cell changes. In peri-menopausal women (who still produce some estrogens) this abnormal antigen release and processing from acinar cells, which reveals cryptic epitopes, together with autoimmunity enhancing effects of estrogens, may lead to the full picture of SS (Cutolo et al., 2004).

This neuroimmunoendocrine working hypothesis would explain many central disease characteristics, but does not provide a final answer to the mystery of this intriguing syndrome as the reasons for the insufficient production and generation of DHEA remain to be solved. We have done some preliminary studies to analyze this topic by mapping the signals of the extracellular matrix in the adrenal cortex, where the cells proliferate in the outer zone and subsequently migrate in a centripetal direction, during which phenotypic transition occurs from the outer zone (zona glomerulosa) cells producing aldosterone to the intermediate zone (zona fasciculata) cells producing glucocorticosteroids and finally to the inner zone (zona reticularis) cells producing DHEA. However, in this research project we have decided to totally focus on the salivary gland acinar cell-sex steroid interactions.

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Conditions studied

  • Sjogren's Syndrome

Keywords

  • Sjögren's syndrome
  • fatigue
  • salivary gland
  • dehydroepiandrosterone
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In context

Sjogren's Syndrome

371 studies on the registry are indexed under Sjogren's Syndrome; 104 are open to participants now.

This study's enrollment of 107 is above the median of 50 across 244 interventional studies indexed under Sjogren's Syndrome.

Browse Sjogren's Syndrome studies →

Lead sponsor

University of Helsinki is the lead sponsor of 129 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
107 participants (actual)

Study arms

  • Placebo comparator
    2

    180 patients divided to two separate groups (each containing 90 patients). This study has a cross-over, wash-out design, which consists of two 4 month treatment period separated by a one month long wash-out period. During one treatment period the patient gets placebo and during one of the treatment periods the patient gets 50mg of dehydroepiandrosterone (DHEA) in the morning.

    Drug: dehydroepiandrosterone

Interventions

  • Drugdehydroepiandrosterone

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

    Also known as: DHEA

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What researchers measure

Primary outcomes

  1. Fatigue

    Time frame: prospective

Secondary outcomes

  1. Quality of life

    Time frame: prospective

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Study locations

1 site
  • Department of Medicine, Helsinki University Central Hospital
    Helsinki, 00029, Finland
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References and documents

Publications

  • 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. PubMed 15593200 ↗
  • 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. PubMed 15940770 ↗
  • 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. PubMed 11409117 ↗
  • 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. PubMed 17665393 ↗
  • 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. PubMed 20191499 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00543166
Lead sponsor
University of Helsinki
Collaborators
Göteborg University, Uppsala University
First posted
Oct 12, 2007
Start date
Feb 2003
Completion
Dec 2009 (estimated)
Last update
Nov 4, 2007

Study contacts

Yrjö Konttinen, MD, PhD
principal investigator · Helsinki University Central Hospital, Helsinki, Finland

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2007. You cannot join it, but the record below documents what was studied.

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