Systemic Lupus ErythematosusPhase 2/3NCT00189124
Dehydroepiandrosterone (DHEA) in Systemic Lupus Erythematosus (SLE) for Coronary Artery Disease (CAD) Prevention
A Phase 2/3 study testing Dehydroepiandrosterone (DHEA) in people with Systemic Lupus Erythematosus, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of DHEA on endothelial dysfunction in patients with systemic lupus by measuring: 1. changes in brachial artery flow-mediated dilatation (FMD) and 2. changes in biomarkers of cardiovascular risk. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Dehydroepiandrosterone (DHEA)
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Jul 2006
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Member of the Michigan Lupus Cohort
- Meet the American College of Rheumatology (ACR) criteria for SLE
- Premenopausal
Who cannot join
- Smoker
- Diabetic
- Prednisone dose > 10 mg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does DHEA Improve Endothelial Dysfunction and Other Cardiovascular Risk Factors in Premenopausal Women With Systemic Lupus?
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.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Dehydroepiandrosterone (DHEA)
- Keywords
- Systemic Lupus Erythematosus, Dehydroepiandrosterone (DHEA), DHEA, SLE, Lupus
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dehydroepiandrosterone (DHEA)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial artery reactivity, by flow mediated dilatation
Secondary outcomes (2)
Changes in biomarkers of SLE
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startSep 2003
- Primary completionDec 2005
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Arthritis Foundation
- Responsible party
- Principal investigator, Wendy Marder, University of Michigan
- Investigators
- Wendy Marder, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00189124
- Sponsor's protocol ID
- 2001-0822
- Status last verified
- May 2016
- First submitted
- 13 Sep 2005
- Last updated
- 18 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does DHEA Improve Endothelial Dysfunction and Other Cardiovascular Risk Factors in Premenopausal Women With Systemic Lupus?
- ClinicalTrials.gov ID
- NCT00189124
- Acronym / sponsor ID
- 2001-0822
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic Lupus Erythematosus, Dehydroepiandrosterone (DHEA), DHEA, SLE, Lupus
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Arthritis Foundation
- Study start
- Sep 2003
- Primary completion
- Dec 2005 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female
- Member of the Michigan Lupus Cohort
- Meet the American College of Rheumatology (ACR) criteria for SLE
- Premenopausal
Key exclusion criteria (3 listed)
- Smoker
- Diabetic
- Prednisone dose > 10 mg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dehydroepiandrosterone (DHEA) | Drug | – |
Primary outcome
Brachial artery reactivity, by flow mediated dilatation
2 secondary outcomes
Changes in biomarkers of SLE
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy Marder, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dehydroepiandrosterone (DHEA) in people with Systemic Lupus Erythematosus, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brachial artery reactivity, by flow mediated dilatation. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2016.