NCT00189124

Brief Summary

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

  1. 1.changes in brachial artery flow-mediated dilatation (FMD) and
  2. 2.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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2003

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

May 18, 2016

Status Verified

May 1, 2016

Enrollment Period

2.3 years

First QC Date

September 13, 2005

Last Update Submit

May 17, 2016

Conditions

Systemic Lupus Erythematosus

Keywords

Systemic Lupus ErythematosusDehydroepiandrosterone (DHEA)DHEASLELupus

Outcome Measures

Primary Outcomes (1)

  • Brachial artery reactivity, by flow mediated dilatation

Secondary Outcomes (2)

  • Changes in biomarkers of SLE

  • Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score

Interventions

Dehydroepiandrosterone (DHEA)DRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Smoker
  • Diabetic
  • Prednisone dose \> 10 mg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Dehydroepiandrosterone

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds17-KetosteroidsKetosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsTestosterone CongenersGonadal Steroid HormonesGonadal Hormones

Study Officials

  • Wendy Marder, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

September 1, 2003

Primary Completion

December 1, 2005

Study Completion

July 1, 2006

Last Updated

May 18, 2016

Record last verified: 2016-05

Locations

US(1)