Dehydroepiandrosterone (DHEA) in Systemic Lupus Erythemat... | NCT00189124

Studies
Dehydroepiandrosterone (DHEA) in Systemic Lupus Erythematosus (SLE) for Coronary Artery Disease (CAD) Prevention

NCT00189124

Sponsor

University of Michigan

Status

Completed

Last Update Posted

May 18, 2016Estimated

Enrollment

13Actual

Phase

Phase 2Phase 3

Conditions

Systemic Lupus Erythematosus

Interventions

Dehydroepiandrosterone (DHEA)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Sep 2003

Primary Completion Date

Dec 2005Actual

Completion Date

Jul 2006Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 17, 2016

Last Update Posted Date

May 18, 2016Estimated

Name	Class
Arthritis Foundation	OTHER

Description Module

Brief Summary

The purpose of this study is to evaluate the effect of DHEA on endothelial dysfunction in patients with systemic lupus by measuring:

changes in brachial artery flow-mediated dilatation (FMD) and
changes in biomarkers of cardiovascular risk. Patients will be enrolled in a randomized, double-blinded crossover trial of DHEA or placebo for ten weeks, then crossed over to the alternate treatment arm after a six-week washout period.

HYPOTHESIS: Dehydroepiandrosterone (DHEA) administration in premenopausal women with SLE modifies cardiovascular risk by improving vascular endothelial function and other biomarkers associated with cardiovascular heart disease.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Name	Type	Description	Arm Group Labels	Other Names
Dehydroepiandrosterone (DHEA)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Brachial artery reactivity, by flow mediated dilatation

Secondary Outcomes

Measure	Description	Time Frame
Changes in biomarkers of SLE
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female
Member of the Michigan Lupus Cohort
Meet the American College of Rheumatology (ACR) criteria for SLE
Premenopausal

Exclusion Criteria:

Smoker
Diabetic
Prednisone dose > 10 mg

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wendy Marder, MD	University of Michigan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Michigan		Ann Arbor	Michigan	48109	United States

Condition Browse Module

MeSH Terms

ID	Term
D008180	Lupus Erythematosus, Systemic

Ancestor Terms

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003687	Dehydroepiandrosterone

Ancestor Terms

ID	Term
D000737	Androstenols
D000736	Androstenes
D000731	Androstanes
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

Not provided