Trial record 10 of 96 for:    Sjogren's Syndrome

DHEA Treatment for Sjogren's Syndrome

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001598
First received: November 3, 1999
Last updated: March 3, 2008
Last verified: June 2002
  Purpose

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.


Condition Intervention Phase
Lacrimal Apparatus Disease
Salivary Gland Disease
Sjogren's Syndrome
Xerostomia
Drug: Dehydroepiandrosterone
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
Official Title: Dehydroepiandrosterone (DHEA) Treatment for Sjogren's Syndrome

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 28
Study Start Date: May 1997
Estimated Study Completion Date: June 2002
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Females with a diagnosis of Primary Sjogren's Syndrome.

No history of breast cancer.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001598

Locations
United States, Maryland
National Institute of Dental And Craniofacial Research (NIDCR)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001598     History of Changes
Other Study ID Numbers: 970123, 97-D-0123
Study First Received: November 3, 1999
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Xerostomia
Autoimmunity
Salivary Glands
Androgen Therapy
Lacrimal Function
DHEA
Sjogren's Syndrome
Dehydroepiandrosterone

Additional relevant MeSH terms:
Sjogren's Syndrome
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Salivary Gland Diseases
Xerostomia
Eye Diseases
Mouth Diseases
Stomatognathic Diseases
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014