- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001598
DHEA Treatment for Sjogren's Syndrome
Dehydroepiandrosterone (DHEA) Treatment for Sjogren's Syndrome
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institute of Dental and Craniofacial Research (NIDCR)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Females with a diagnosis of Primary Sjogren's Syndrome.
No history of breast cancer.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Autoimmune Diseases
- Eye Diseases
- Disease
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Arthritis
- Stomatognathic Diseases
- Mouth Diseases
- Arthritis, Rheumatoid
- Dry Eye Syndromes
- Syndrome
- Sjogren's Syndrome
- Lacrimal Apparatus Diseases
- Xerostomia
- Salivary Gland Diseases
- Physiological Effects of Drugs
- Immunologic Factors
- Adjuvants, Immunologic
- Dehydroepiandrosterone
Other Study ID Numbers
- 970123
- 97-D-0123
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sjogren's Syndrome
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The Cleveland ClinicBristol-Myers SquibbWithdrawnRheumatoid Arthritis | Inflammatory Arthritis | Primary Sjogren's Syndrome | Secondary Sjogren's SyndromeUnited States
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RemeGen Co., Ltd.RecruitingPrimary Sjogren's SyndromeChina
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Stanford UniversityWithdrawnPrimary Sjogren's Syndrome
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Matthew C. BakerWithdrawnPrimary Sjogren's SyndromeUnited States
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University College, LondonCambridge University Hospitals NHS Foundation Trust; Sheffield Teaching Hospitals... and other collaboratorsActive, not recruitingSjogren's Syndrome Childhood-onsetUnited Kingdom, Ireland
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Keio UniversityUnknown
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Parion SciencesCompletedXerostomia | Dry Mouth Associated With Sjogren's SyndromeUnited States
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University Hospital MuensterNovartisCompletedPrimary Sjogren's SyndromeGermany
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Akdeniz UniversityCompleted
Clinical Trials on Dehydroepiandrosterone
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National Center for Research Resources (NCRR)Northwestern UniversityCompleted
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Inflabloc PharmaceuticalsCompletedAn Efficacy and Safety Evaluation of Inflabloc Cap in the Treatment of Patients With Crohn's DiseaseCrohn's DiseaseUnited States, Canada
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University of HelsinkiUppsala University; Göteborg UniversityUnknownSjogren's SyndromeFinland
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EndoCeutics Inc.Completed
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Monash UniversityCompletedQuality of Life | Menopausal Syndrome | Libido DisorderAustralia
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Taipei Veterans General Hospital, TaiwanNational YangMing UniversityCompletedDehydroepiandrosterone | DHEAS | Gene Expression of Cumulus Cells. | Ovarian Hyper-stimulation Protocol. | Artificial Reproduction Technology.Taiwan
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National Center for Research Resources (NCRR)Northwestern UniversityCompletedSystemic Lupus Erythematosus
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National Center for Research Resources (NCRR)Northwestern UniversityCompleted
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Meir Medical CenterCompletedOvarian StimulationIsrael
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Chinese University of Hong KongTerminatedGenitourinary Syndrome of MenopauseHong Kong