Dehydroepiandrosterone Administration in Women With Systemic Lupus Erythematosus or Primary Sjögren's Syndrome

October 24, 2006 updated by: UMC Utrecht

Fatigue and General Well-Being in Patients With Systemic Lupus Erythematosus or Primary Sjögren's Syndrome: Effects of Dehydroepiandrosterone Administration

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9700RB
        • University Medical Center Groningen
      • Utrecht, Netherlands, 3508GA
        • University Medical Center Utrecht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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)

Secondary Outcome Measures

Outcome Measure
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Collaborators

University Medical Center Groningen
Dutch Arthritis Association

Investigators

  • Study Chair: Ronald HW Derksen, MD,PhD, UMC Utrecht

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2000

Study Completion

January 1, 2003

Study Registration Dates

First Submitted

October 24, 2006

First Submitted That Met QC Criteria

October 24, 2006

First Posted (Estimate)

October 25, 2006

Study Record Updates

Last Update Posted (Estimate)

October 25, 2006

Last Update Submitted That Met QC Criteria

October 24, 2006

Last Verified

October 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NR 98-2-301

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.

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