Erectile DysfunctionPhase 4NCT01084187
Correlation Study of Vascular Parameters in Hypertensive Men With Erectile Dysfunction
A Phase 4 study testing Vardenafil in people with Erectile Dysfunction and Arterial Hypertension, run by Hospital Universitario Pedro Ernesto at 1 site in Brazil.
Trial summary
The purpose of the study is to assess the correlation of FMD of brachial artery and carotid intima media thickness with ED severity and clinical response to vardenafil in hypertensive men. Read more about this study
- Who is it for?
- Ages 50 to 70 years, men only
- Conditions the study is for
- Erectile Dysfunction, Arterial Hypertension, Endothelial Dysfunction
- What is being tested?
- Vardenafil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2010to Feb 2011
- Phase
- Phase 4
- 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 50 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- arterial hypertension and erectile dysfunction of vascular origin for at least 6 month
Who cannot join
- other condition that cause erectile dysfunction such as depression, hypogonadism, surgery, trauma, major cardiovascular event
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Universitário Pedro Ernesto
Rio de Janeiro, Rio de Janeiro, 20551030
About this study
Official title: Correlation of Flow Mediated Dilation of Brachial Artery and Carotid Intima Media Thickness With Erectile Dysfunction Severity and Clinical Response to PDE 5 Inhibitor in Hypertensive Men
The purpose of the study is to assess the correlation of FMD of brachial artery and carotid intima media thickness with ED severity and clinical response to vardenafil in hypertensive men.
Read the detailed description
To achieve this objective, a prospective study will be conducted, with hypertensive patients ranging from 50 to 70 years, presenting vasculogenic erectile dysfunction for over six months and sexually actives. All patients will be assessed for clinical and laboratorial data, endothelial dysfunction, endothelium independent vasodilation and carotid intima media thickness at the inclusion of the study. They will receive medical orientations from the same urologist and will return after four attempts with 20 mg of vardenafil.
- Being tested
- Vardenafil
- Keywords
- erectile dysfunction, arterial hypertension, flow mediated vasodilation, endothelial dysfunction, carotid intima media thickness, vardenafil
- Medical subject headings
- Erectile Dysfunction, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VardenafilDrug
Also called Levitra
vardenafil 20 mg on demand or vardenafil daily or placebo
| Study group | Role | What they receive |
|---|---|---|
| vardenafil on demand | Active comparator | four sexual attempts with 20 mg vardenafil during next four weeks Receives: Drug: Vardenafil |
| placebo | Placebo comparator | placebo of vardenafil during four weeks Receives: Drug: Vardenafil |
| daily vardenafil | Active comparator | 10 mg of vardenafil each day during four weeks Receives: Drug: Vardenafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical response to vardenafil
SEP 2; SEP 3 and IIEF variation
Measured: four weeks
Secondary outcomes (1)
endothelial dysfunction
variation of FMD of brachial artery from baseline
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Pedro Ernesto
- Sponsor type
- University, hospital or other
- Investigators
- Mario F Neves, MD, PhD., Study chair, Hospital Universitario Pedro ErnestoValter Javaroni, MD, MSc, Principal investigator, State University of Rio de JaneiroWille Oigman, MD, PhD, Study director, State University of Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084187
- Sponsor's protocol ID
- EDAH2010
- Status last verified
- Apr 2011
- First submitted
- 9 Mar 2010
- Last updated
- 18 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Flow Mediated Dilation of Brachial Artery and Carotid Intima Media Thickness With Erectile Dysfunction Severity and Clinical Response to PDE 5 Inhibitor in Hypertensive Men
- ClinicalTrials.gov ID
- NCT01084187
- Acronym / sponsor ID
- EDAH2010
- Keywords
- erectile dysfunction, arterial hypertension, flow mediated vasodilation, endothelial dysfunction, carotid intima media thickness, vardenafil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hospital Universitario Pedro ErnestoUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 10 Mar 2010 (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 the study is to assess the correlation of FMD of brachial artery and carotid intima media thickness with ED severity and clinical response to vardenafil in hypertensive men.
Detailed description
To achieve this objective, a prospective study will be conducted, with hypertensive patients ranging from 50 to 70 years, presenting vasculogenic erectile dysfunction for over six months and sexually actives. All patients will be assessed for clinical and laboratorial data, endothelial dysfunction, endothelium independent vasodilation and carotid intima media thickness at the inclusion of the study. They will receive medical orientations from the same urologist and will return after four attempts with 20 mg of vardenafil.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| vardenafil on demand | Active comparator | Drug: Vardenafilfour sexual attempts with 20 mg vardenafil during next four weeks |
| placebo | Placebo comparator | Drug: Vardenafilplacebo of vardenafil during four weeks |
| daily vardenafil | Active comparator | Drug: Vardenafil10 mg of vardenafil each day during four weeks |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- arterial hypertension and erectile dysfunction of vascular origin for at least 6 month
Key exclusion criteria (1 listed)
- other condition that cause erectile dysfunction such as depression, hypogonadism, surgery, trauma, major cardiovascular event
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 |
|---|---|---|
| VardenafilAlso: Levitravardenafil 20 mg on demand or vardenafil daily or placebo | Drug | daily vardenafil, placebo, vardenafil on demand |
Primary outcome
clinical response to vardenafil
Time frame: four weeks
SEP 2; SEP 3 and IIEF variation
1 secondary outcome
endothelial dysfunction
Time frame: four weeks
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 Apr 2011.
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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.
Mario F Neves, MD, PhD. study chair
Hospital Universitario Pedro Ernesto
Valter Javaroni, MD, MSc principal investigator
State University of Rio de Janeiro
Wille Oigman, MD, PhD study director
State University of Rio de Janeiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vardenafil in people with Erectile Dysfunction and Arterial Hypertension, run by Hospital Universitario Pedro Ernesto at 1 site in Brazil.
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 1 inclusion and 1 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 Apr 2011. 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 Brazil. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
clinical response to vardenafil (time frame: four weeks). 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 Apr 2011.