- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03038659
Role of Intima-media Thickness in Determining Arteriogenic Erectile Dysfunction
January 31, 2017 updated by: Ahmad Raef Sadek, Adam International Hospital
Predictive Value of Measuring Intima-media Thickness of Cavernosal Artery in Diagnosis of Arteriogenic Erectile Dysfunction by Penile Duplex
Erectile dysfunction.
Study Overview
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 Type
Observational
Enrollment (Actual)
70
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Sampling Method
Probability Sample
Study Population
Erectile dysfunction pateints
Description
Inclusion Criteria:
- Erectile dysfunction patients
Exclusion Criteria:
- Penile trauma.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Penile Duplex
Measuring intima media thickness
|
Measuring intima media thickness
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
erectile dysfunction
Time Frame: six months
|
intima media thickness
|
six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2016
Primary Completion (Actual)
January 1, 2017
Study Completion (Actual)
January 29, 2017
Study Registration Dates
First Submitted
January 29, 2017
First Submitted That Met QC Criteria
January 31, 2017
First Posted (Estimate)
February 1, 2017
Study Record Updates
Last Update Posted (Estimate)
February 1, 2017
Last Update Submitted That Met QC Criteria
January 31, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Erectile dysfunction
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.