Erectile DysfunctionNCT03038659
Role of Intima-media Thickness in Determining Arteriogenic Erectile Dysfunction
An observational study of Erectile Dysfunction, run by Adam International Hospital.
Trial summary
Erectile dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Penile Duplex
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2016to 29 Jan 2017
- Phase
- Observational
- 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 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Erectile dysfunction pateints
Who may be able to join
- Erectile dysfunction patients
Who cannot join
- Penile trauma.
About this study
Official title: Predictive Value of Measuring Intima-media Thickness of Cavernosal Artery in Diagnosis of Arteriogenic Erectile Dysfunction by Penile Duplex
Erectile dysfunction.
Read the detailed description
The intima media thickness is increasingly used as a surrogate end point of vascular outcomes in clinical trials aimed at determining the success of interventions that lower risk factors for atherosclerosis and associated diseases (stroke, myocardial infarction and peripheral artery diseases, like disease of cavernosal artery). The investigators hypothesized that the IMT of cavernosal artery would add to the predictive value of vasculogenic erectile dysfunction risk and outcomes. This study seeks to evaluate these hypotheses with our experience, investigating the predictive accuracy of Cavernosal Doppler ultrasound findings for discriminating patients with vasculogenic erectile dysfunction.
- Conditions
- Erectile Dysfunction
- Being tested
- Penile Duplex
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Penile DuplexDevice
Measuring intima media thickness
| Study group | Role | What they receive |
|---|---|---|
| Penile Duplex | Measuring intima media thickness Receives: Device: Penile Duplex |
What is being measured
The primary outcome is the main question the study is designed to answer.
erectile dysfunction
intima media thickness
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study start1 Jul 2016
- Primary completion1 Jan 2017
- Study completion29 Jan 2017
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adam International Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Raef Sadek, Adam International Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03038659
- Sponsor's protocol ID
- 2018
- Status last verified
- Jan 2017
- First submitted
- 29 Jan 2017
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Erectile dysfunction
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Measuring Intima-media Thickness of Cavernosal Artery in Diagnosis of Arteriogenic Erectile Dysfunction by Penile Duplex
- ClinicalTrials.gov ID
- NCT03038659
- Acronym / sponsor ID
- 2018
- Conditions
- Erectile Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Adam International HospitalUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 29 Jan 2017 (actual)
- First posted
- 1 Feb 2017 (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.
Erectile dysfunction.
Detailed description
The intima media thickness is increasingly used as a surrogate end point of vascular outcomes in clinical trials aimed at determining the success of interventions that lower risk factors for atherosclerosis and associated diseases (stroke, myocardial infarction and peripheral artery diseases, like disease of cavernosal artery). The investigators hypothesized that the IMT of cavernosal artery would add to the predictive value of vasculogenic erectile dysfunction risk and outcomes. This study seeks to evaluate these hypotheses with our experience, investigating the predictive accuracy of Cavernosal Doppler ultrasound findings for discriminating patients with vasculogenic erectile dysfunction.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Penile Duplex | – | Device: Penile DuplexMeasuring intima media thickness |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Erectile dysfunction pateints
Key inclusion criteria (1 listed)
- Erectile dysfunction patients
Key exclusion criteria (1 listed)
- Penile trauma.
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 |
|---|---|---|
| Penile DuplexMeasuring intima media thickness | Device | Penile Duplex |
Primary outcome
erectile dysfunction
Time frame: six months
intima media thickness
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 1 Feb 2017.
- Individual participant dataSharing planned: No. Erectile dysfunction
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Erectile Dysfunction, run by Adam International Hospital.
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 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
erectile dysfunction (time frame: six months). 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 1 Feb 2017.