Completed

Dehydroepiandrosterone (DHEA) Treatment for Sjogren's Syndrome

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What is being tested

Dehydroepiandrosterone

Drug
Who is being recruted

Arthritis+14

+ Arthritis, Rheumatoid

+ Connective Tissue Diseases

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: May 1997
See protocol details

Summary

Principal SponsorNational Institute of Dental and Craniofacial Research (NIDCR)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 1997

Actual date on which the first participant was enrolled.

Primary Sjogren's syndrome (SS) is an autoimmune disease chiefly affecting the exocrine glands. One of the most troublesome manifestations of SS is severe salivary gland dysfunction. There is no accepted treatment for the underlying autoimmune reactivity or the salivary gland dysfunction in SS. SS, as well as many other autoimmune diseases, predominantly affects women. Although sex hormones do not cause SS or other autoimmune disease, they appear to influence immunological responses and ultimately the severity of disease. We propose to test the effects of dehydroepiandrosterone (DHEA), a mildly androgenic adrenal hormone, on lacrimal and salivary gland function in SS. In a randomized, double-masked, outpatient protocol, patients will receive DHEA for 6 months. Efficacy of treatment will be assessed by monitoring salivary and lacrimal function, serological markers of autoimmune activity, and subjective reports of local and systemic symptoms.

NCT00001598
Principal SponsorNational Institute of Dental and Craniofacial Research (NIDCR)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

28 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisArthritis, RheumatoidConnective Tissue DiseasesEye DiseasesImmune System DiseasesJoint DiseasesStomatognathic DiseasesMouth DiseasesMusculoskeletal DiseasesRheumatic DiseasesDry Eye SyndromesSkin and Connective Tissue DiseasesAutoimmune DiseasesLacrimal Apparatus DiseasesSalivary Gland DiseasesSjogren's SyndromeXerostomia

Criteria

Females with a diagnosis of Primary Sjogren's Syndrome. No history of breast cancer.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Institute of Dental And Craniofacial Research (NIDCR)

Bethesda, United StatesOpen National Institute of Dental And Craniofacial Research (NIDCR) in Google Maps
CompletedOne Study Center