Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 14 of 236 for:    PRASTERONE

Dehydroepiandrosterone Administration in Women With Systemic Lupus Erythematosus or Primary Sjögren'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: NCT00391924
Recruitment Status : Completed
First Posted : October 25, 2006
Last Update Posted : October 25, 2006
Sponsor:
Collaborators:
University Medical Center Groningen
Dutch Arthritis Association
Information provided by:
UMC Utrecht

Tracking Information
First Submitted Date  ICMJE October 24, 2006
First Posted Date  ICMJE October 25, 2006
Last Update Posted Date October 25, 2006
Study Start Date  ICMJE May 2000
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2006)
  • General fatigue
  • Depressive mood
  • Mental well-being
  • Physical functioning
  • (all measures at baseline, after 3, 6, and 12 months of intake of study medication, and 6 months after cessation of medication intake)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2006)
  • Self-reported pain,
  • Fibromyalgia tender points
  • Erythrocyte sedimentation rate
  • Hemoglobin
  • Serum Immunoglobulin-G
  • Self-reported ocular dryness (in pSS only)
  • Self-reported oral dryness (in pSS only)
  • Ocular tear production (in pSS only)
  • SLE disease activity index (in SLE only)
  • Bone mineral density (in SLE only)
  • Dose of glucocorticoids (in SLE only)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dehydroepiandrosterone Administration in Women With Systemic Lupus Erythematosus or Primary Sjögren's Syndrome
Official Title  ICMJE Fatigue and General Well-Being in Patients With Systemic Lupus Erythematosus or Primary Sjögren's Syndrome: Effects of Dehydroepiandrosterone Administration
Brief Summary The purpose of the study is to examine whether dehydroepiandrosterone (DHEA) administration improves fatigue and general well-being in patients with systemic lupus erythematosus or primary Sjögren's syndrome
Detailed Description Fatigue and reduced general well-being are frequent complaints in patients with the chronic autoimmune disorder systemic lupus erythematosus (SLE) or primary Sjögren's syndrome (pSS). Uncontrolled studies suggested that the administration of dehydroepiandrosterone (DHEA) may improve such complaints. The aim of our randomized double-blind placebo-controlled study is to examine the effect of daily oral 200 mg DHEA on fatigue, well-being, and functioning in women with SLE or pSS.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Lupus Erythematosus, Systemic
  • Sjogren's Syndrome
Intervention  ICMJE Drug: Dehydroepiandrosterone
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: October 24, 2006)
120
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE January 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • pSS with a focus score >= 1 on minor salivary gland biopsy and fulfilling European classification criteria (Ann Rheum Dis 1996;55:116-21)
  • SLE according to ACR classification criteria (Arthritis Rheum 1982;25:1271-7)
  • Willingness to apply effective contraception (premenopausal women)
  • Written informed consent.

Exclusion Criteria:

  • Pregnancy
  • Pregnancy wish
  • Serum creatinine > 150 µmol/L
  • Glucocorticoid use at a daily dose > 10 mg prednisone (or equivalent)
  • Cyclophosphamide treatment in the preceding year
  • Hyper- or hypothyroidism
  • History of malignancy within the previous 5 years with exception of squamous or basal cell carcinoma of the skin
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00391924
Other Study ID Numbers  ICMJE NR 98-2-301
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE UMC Utrecht
Collaborators  ICMJE
  • University Medical Center Groningen
  • Dutch Arthritis Association
Investigators  ICMJE
Study Chair: Ronald HW Derksen, MD,PhD UMC Utrecht
PRS Account UMC Utrecht
Verification Date October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP