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

NCT00543166 | Unknown Phase 4 DMC

• 1 other identifier: T101090002
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Sjögren's syndrome; fatigue; salivary gland; dehydroepiandrosterone

Outcome Measures

Primary Outcomes (1)

• Fatigue

  prospective

Secondary Outcomes (1)

• Quality of life

  prospective

Study Arms (1)

2

PLACEBO COMPARATOR

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

dehydroepiandrosterone DRUG

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

Also known as: DHEA

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary SS according to the American-European consensus criteria
• 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)
• subnormal serum S-DHEAS values (the reference values were calculated based on a pilot study of 81 healthy women and 57 healthy men).

You may not qualify if:

• Age \<18 years or \>80 years
• prisoner
• individuals not able to give their informed consent
• history of breast cancer
• history of uterus cancer
• history of prostatic cancer
• history of stroke or prothrombotic coagulation disorders
• pregnant or lactating women
• fertile patients without adequate prevention
• difficult acne
• a significant liver disease
• 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

Sponsors & Collaborators

• University of Helsinki: lead
• Göteborg University: collaborator
• Uppsala University: collaborator

Study Sites (1)

Department of Medicine, Helsinki University Central Hospital

Helsinki, Helsinki, 00029, Finland

Location

Related Publications (5)

• 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.

  PMID: 15593200 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.

  PMID: 15940770 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.

  PMID: 11409117 BACKGROUND

• 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.

  PMID: 17665393 RESULT

• 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.

  PMID: 20191499 DERIVED

MeSH Terms

Conditions

Sjogren's Syndrome; Fatigue

Interventions

Dehydroepiandrosterone

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Ketosteroids; Ketosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Officials

• Yrjö Konttinen, MD, PhD

  Helsinki University Central Hospital, Helsinki, Finland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 9, 2007
• First Posted: October 12, 2007
• Study Start: February 1, 2003
• Study Completion: December 1, 2009
• Last Updated: November 5, 2007

Record last verified: 2007-10

Locations

FI (1)