Evaluation of the Relationship Between Serum Biomarkers (Endocan and ADMA) and Penile Doppler Ultrasonography Findings of Patients With Severe Erectile DysfNCT05979467
The Relationship Between Serum Endocan and ADMA Levels and Penile Doppler Ultrasonography in Erectile Dysfunction
An observational study of Evaluation of the Relationship Between Serum Biomarkers (Endocan and ADMA) and Penile Doppler Ultrasonography Findings of Patients With Severe Erectile Dysf, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
The gold standard diagnosis in patients admitted to the hospital with the complaint of erectile dysfunction is penile doppler ultrasonography. This procedure is an invasive procedure and can cause various complications. Read more about this study
- Who is it for?
- Ages 50 to 70 years, men only
- Conditions the study is for
- Evaluation of the Relationship Between Serum Biomarkers (Endocan and ADMA) and Penile Doppler Ultrasonography Findings of Patients With Severe Erectile Dysf
- How many people
- 73 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Apr 2017to 12 Jun 2020
- 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 50 to 70 years
- Men only
- Adult, Older adult
Study population: tertiary care clinic
Who may be able to join
- Patients with severe erectile dysfunction according to International Index of Erectile Function-15 questionnaire
- Patients who have not received medical or surgical treatment before
- Patients without comorbidity and related drug use
Who cannot join
- Patients who have had previous pelvic trauma or surgery,
- Patients who have benefited from using phosphodiesterase-5 enzyme inhibitors,
- Patients with psychogenic erectile dysfunction and moderate or mild erectile dysfunction according to International Index of Erectile Function-15 questionnaire,
- Patients who have neurological disease, chronic liver disease and patients with chronic renal failure and those who used drugs that could cause erectile dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Serum Endocan and ADMA Levels and Penile Doppler Ultrasonography Findings in Patients With Vasculogenic Erectile Dysfunction
The gold standard diagnosis in patients admitted to the hospital with the complaint of erectile dysfunction is penile doppler ultrasonography. This procedure is an invasive procedure and can cause various complications. Therefore, in this study, we aimed to support and define the diagnosis of erectile dysfunction with some biomarkers that can be measured in blood samples. At this point, we performed penile doppler ultrasonography, which is the gold standard test, for all patients who applied with the complaint of erectile dysfunction, and compared the results of penile doppler and serum biomarkers in the patients.
- Keywords
- Erectile dysfunction, Endocan, ADMA, Penile Doppler
- Medical subject headings
- Erectile Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the relationship between serum endocan (endothelial cell-specific molecule-1), ADMA (asymmetric dimethylarginine) values and penile Doppler ultrasonography findings in patients with severe Erectile dysfunction.
Measured: 10 days from the outpatient clinic admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start17 Apr 2017
- Primary completion20 Jan 2020
- Study completion12 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluation of the Relationship Between Serum Biomarkers (Endocan and ADMA) and Penile Doppler Ultrasonography Findings of Patients With Severe Erectile DysfStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Cagri Akpinar, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05979467
- Sponsor's protocol ID
- E-18-23-52
- Status last verified
- Jul 2023
- First submitted
- 28 Jul 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Serum Endocan and ADMA Levels and Penile Doppler Ultrasonography Findings in Patients With Vasculogenic Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT05979467
- Acronym / sponsor ID
- E-18-23-52
- Keywords
- Erectile dysfunction, Endocan, ADMA, Penile Doppler
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 17 Apr 2017 (actual)
- Primary completion
- 20 Jan 2020 (actual)
- Study completion
- 12 Jun 2020 (actual)
- First posted
- 7 Aug 2023 (actual)
- 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 gold standard diagnosis in patients admitted to the hospital with the complaint of erectile dysfunction is penile doppler ultrasonography. This procedure is an invasive procedure and can cause various complications. Therefore, in this study, we aimed to support and define the diagnosis of erectile dysfunction with some biomarkers that can be measured in blood samples. At this point, we performed penile doppler ultrasonography, which is the gold standard test, for all patients who applied with the complaint of erectile dysfunction, and compared the results of penile doppler and serum biomarkers in the patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- tertiary care clinic
Key inclusion criteria (3 listed)
- Patients with severe erectile dysfunction according to International Index of Erectile Function-15 questionnaire
- Patients who have not received medical or surgical treatment before
- Patients without comorbidity and related drug use
Key exclusion criteria (4 listed)
- Patients who have had previous pelvic trauma or surgery,
- Patients who have benefited from using phosphodiesterase-5 enzyme inhibitors,
- Patients with psychogenic erectile dysfunction and moderate or mild erectile dysfunction according to International Index of Erectile Function-15 questionnaire,
- Patients who have neurological disease, chronic liver disease and patients with chronic renal failure and those who used drugs that could cause erectile dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the relationship between serum endocan (endothelial cell-specific molecule-1), ADMA (asymmetric dimethylarginine) values and penile Doppler ultrasonography findings in patients with severe Erectile dysfunction.
Time frame: 10 days from the outpatient clinic admission
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 7 Aug 2023.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Evaluation of the Relationship Between Serum Biomarkers (Endocan and ADMA) and Penile Doppler Ultrasonography Findings of Patients With Severe Erectile Dysf, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 4 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 7 Aug 2023. 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 Turkey (Türkiye). 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.
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?
To evaluate the relationship between serum endocan (endothelial cell-specific molecule-1), ADMA (asymmetric dimethylarginine) values and penile Doppler ultrasonography findings in patients with severe Erectile dysfunction. (time frame: 10 days from the outpatient clinic admission). 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 7 Aug 2023.