DHEA Treatment for Sjogren's Syndrome
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00001598 |
Recruitment Status :
Completed
First Posted : November 4, 1999
Last Update Posted : March 4, 2008
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 or disease | Intervention/treatment | Phase |
---|---|---|
Lacrimal Apparatus Disease Salivary Gland Disease Sjogren's Syndrome Xerostomia | Drug: Dehydroepiandrosterone | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 28 participants |
Primary Purpose: | Treatment |
Official Title: | Dehydroepiandrosterone (DHEA) Treatment for Sjogren's Syndrome |
Study Start Date : | May 1997 |
Study Completion Date : | June 2002 |


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, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Females with a diagnosis of Primary Sjogren's Syndrome.
No history of breast cancer.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001598
United States, Maryland | |
National Institute of Dental And Craniofacial Research (NIDCR) | |
Bethesda, Maryland, United States, 20892 |
ClinicalTrials.gov Identifier: | NCT00001598 |
Other Study ID Numbers: |
970123 97-D-0123 |
First Posted: | November 4, 1999 Key Record Dates |
Last Update Posted: | March 4, 2008 |
Last Verified: | June 2002 |
Xerostomia Autoimmunity Salivary Glands Androgen Therapy |
Lacrimal Function DHEA Sjogren's Syndrome Dehydroepiandrosterone |
Sjogren's Syndrome Xerostomia Salivary Gland Diseases Lacrimal Apparatus Diseases Syndrome Disease Pathologic Processes Arthritis, Rheumatoid Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
Mouth Diseases Stomatognathic Diseases Dry Eye Syndromes Eye Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Dehydroepiandrosterone Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |