DHEA Treatment for Sjogren's Syndrome

NCT00001598 | Completed Phase 2

• 2 other identifiers: 97012397-D-0123
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the effectiveness of the male hormone dehydroepiandrosterone (DHEA) in treating Sjogren's syndrome. This autoimmune disorder, in which the immune system attacks the salivary glands and tear glands, affects primarily women. Patients' eyes and mouth become drier over time, and can lead to problems such as serious tooth decay and eye irritations. Sex hormones seem to influence the immune response and may help decrease disease severity. DHEA has benefited some patients with two other autoimmune diseases, rheumatoid arthritis and systemic lupus erythematosus. Women 18 to 75 years of age with Sjogren's syndrome may be eligible for this 7-month study. At the initial visit, candidates will have a physical examination, routine blood and urine tests and eye and dental examinations, including a test to measure saliva production for screening purposes and to establish baseline values for participants. Those enrolled in the study will be randomly assigned to take either DHEA or placebo (look-alike tablet with no active ingredient) once a day for 6 months and will be monitored with follow-up visits at months 1, 3, 6 and 7. Physical examination, blood tests and urinalysis will be repeated at months 1, 3, 6 and 7; saliva will be collected at months 3, 6 and 7; and eyes will be examined at 3 and 6 months. Because hormone changes may have both physical and emotional effects, patients will be asked questions about their mood, symptoms and side effects of treatment. It is not known if Sjogren's syndrome is associated with osteoporosis (bone thinning), but since this condition occurs in other autoimmune disorders, patient's bone density will be measured at the first visit, and blood drawn at 3 and 6 months will be tested for various substances associated with changes in bone density. A 24-hour urine collection at the first visit and later urine tests will also be tested for substances associated with bone thinning.

Conditions

Salivary Gland Disease; Lacrimal Apparatus Disease; Sjogren's Syndrome; Xerostomia

Keywords

Xerostomia; Autoimmunity; Salivary Glands; Androgen Therapy; Lacrimal Function; DHEA; Sjogren's Syndrome; Dehydroepiandrosterone

Interventions

Dehydroepiandrosterone DRUG

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Dental and Craniofacial Research (NIDCR): lead

Study Sites (1)

National Institute of Dental And Craniofacial Research (NIDCR)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Johnson JT, Ferretti GA, Nethery WJ, Valdez IH, Fox PC, Ng D, Muscoplat CC, Gallagher SC. Oral pilocarpine for post-irradiation xerostomia in patients with head and neck cancer. N Engl J Med. 1993 Aug 5;329(6):390-5. doi: 10.1056/NEJM199308053290603.

  PMID: 8326972 BACKGROUND

• van Vollenhoven RF, Engleman EG, McGuire JL. An open study of dehydroepiandrosterone in systemic lupus erythematosus. Arthritis Rheum. 1994 Sep;37(9):1305-10. doi: 10.1002/art.1780370906.

  PMID: 7945493 BACKGROUND

• Lucas JA, Ahmed SA, Casey ML, MacDonald PC. Prevention of autoantibody formation and prolonged survival in New Zealand black/New Zealand white F1 mice fed dehydroisoandrosterone. J Clin Invest. 1985 Jun;75(6):2091-3. doi: 10.1172/JCI111929.

  PMID: 3159756 BACKGROUND

MeSH Terms

Conditions

Lacrimal Apparatus Diseases; Salivary Gland Diseases; Sjogren's Syndrome; Xerostomia; Autoimmune Diseases

Interventions

Dehydroepiandrosterone

Condition Hierarchy (Ancestors)

Eye Diseases; Mouth Diseases; Stomatognathic Diseases; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Dry Eye Syndromes; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases

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 Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: May 1, 1997
• Study Completion: June 1, 2002
• Last Updated: March 4, 2008

Record last verified: 2002-06

Locations

US (1)