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

NCT ID: NCT00391924

Last Updated: 2006-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-05-31

Study Completion Date

2003-01-31

Brief Summary

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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

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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.

Conditions

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Lupus Erythematosus, Systemic Sjogren's Syndrome

Keywords

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Dehydroepiandrosterone Fatigue Quality of life Lupus Erythematosus, Systemic Sjogren's Syndrome Bone mineral density

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Dehydroepiandrosterone

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role collaborator

Dutch Arthritis Association

INDUSTRY

Sponsor Role collaborator

UMC Utrecht

OTHER

Sponsor Role lead

Principal Investigators

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Ronald HW Derksen, MD,PhD

Role: STUDY_CHAIR

UMC Utrecht

Locations

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University Medical Center Groningen

Groningen, , Netherlands

Site Status

University Medical Center Utrecht

Utrecht, , Netherlands

Site Status

Countries

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Netherlands

References

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Hartkamp A, Geenen R, Godaert GL, Bijl M, Bijlsma JW, Derksen RH. The effect of dehydroepiandrosterone on lumbar spine bone mineral density in patients with quiescent systemic lupus erythematosus. Arthritis Rheum. 2004 Nov;50(11):3591-5. doi: 10.1002/art.20610.

Reference Type RESULT
PMID: 15529389 (View on PubMed)

Hartkamp A, Geenen R, Bijl M, Kruize AA, Godaert GL, Derksen RH. Serum cytokine levels related to multiple dimensions of fatigue in patients with primary Sjogren's syndrome. Ann Rheum Dis. 2004 Oct;63(10):1335-7. doi: 10.1136/ard.2003.011825.

Reference Type RESULT
PMID: 15361396 (View on PubMed)

Hartkamp A, Geenen R, Godaert GL, Bijl M, Bijlsma JW, Derksen RH. Effects of dehydroepiandrosterone on fatigue and well-being in women with quiescent systemic lupus erythematosus: a randomised controlled trial. Ann Rheum Dis. 2010 Jun;69(6):1144-7. doi: 10.1136/ard.2009.117036. Epub 2009 Oct 22.

Reference Type DERIVED
PMID: 19854713 (View on PubMed)

Other Identifiers

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NR 98-2-301

Identifier Type: -

Identifier Source: org_study_id