Erectile DysfunctionNCT05109377
Endocan Level in Patients With Erectile Dysfunction and Relationship With Tadalafil Treatment
A study testing Endocan and tadalafil in people with Erectile Dysfunction, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The investigators analyze the patients' endocan levels, IIEF scores, and hormon levels both before and after tadalafil (5 or 20mg) treatment. The investigators want to see erectile dysfunction severity and tadalafil treatment relations with endocen level. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Endocan and tadalafil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Jun 2021to 15 Dec 2021
- Phase
- Interventional
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with erectile dysfuction
Who cannot join
- Psychogenic erectile dysfunction
- Erectile dysfunction associated with hormonal disorders
- Drug related erectile dysfunction
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Veysel Bayburtluoğlu
Ankara
Veysel Bayburtluoğlu
About this study
The investigators analyze the patients' endocan levels, IIEF scores, and hormon levels both before and after tadalafil (5 or 20mg) treatment. The investigators want to see erectile dysfunction severity and tadalafil treatment relations with endocen level.
Read the detailed description
The investigators will include at least 90 patients in study. Blood tests will taken before and after tadalafil treatment and will store at -80 celcius degree.
- Conditions
- Erectile Dysfunction
- Being tested
- Endocan, tadalafil
- Keywords
- Endocan, Erectile dysfunction, Tadalafil
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndocanDiagnostic test
Endocan will measured before and after treatment
tadalafilDrug
tadalafil
| Study group | Role | What they receive |
|---|---|---|
| 5mg tadalafil | Other | 5mg tadalafil Receives: Diagnostic Test: Endocan; Drug: tadalafil |
| 20mg tadalafil | Other | 20 mg tadalafil Receives: Diagnostic Test: Endocan; Drug: tadalafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of IIEF Score
Levels of Endocan relationship with IIEF
Measured: 1 month
Secondary outcomes (1)
Levels of Endocan
Levels of Endocan with tadalafil treatment
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start24 Jun 2021
- Primary completion15 Nov 2021 (estimated)
- Study completion15 Dec 2021 (estimated)
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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veysel Bayburtluoğlu, Ankara Training and Research Hospital
- Investigators
- Veysel Bayburtluoğlu, Principal investigator, Ministry of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109377
- Sponsor's protocol ID
- E-93471371-514.10
- Status last verified
- Nov 2021
- First submitted
- 4 Sep 2021
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Research data
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endocan Level in Patients With Erectile Dysfunction and Relationship With Tadalafil Treatment
- ClinicalTrials.gov ID
- NCT05109377
- Acronym / sponsor ID
- E-93471371-514.10
- Conditions
- Erectile Dysfunction
- Keywords
- Endocan, Erectile dysfunction, Tadalafil
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ankara Training and Research HospitalUniversity, hospital or other
- Study start
- 24 Jun 2021 (actual)
- Primary completion
- 15 Nov 2021 (estimated)
- Study completion
- 15 Dec 2021 (estimated)
- First posted
- 5 Nov 2021 (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 investigators analyze the patients' endocan levels, IIEF scores, and hormon levels both before and after tadalafil (5 or 20mg) treatment. The investigators want to see erectile dysfunction severity and tadalafil treatment relations with endocen level.
Detailed description
The investigators will include at least 90 patients in study. Blood tests will taken before and after tadalafil treatment and will store at -80 celcius degree.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5mg tadalafil | Other | Diagnostic Test: Endocan, Drug: tadalafil5mg tadalafil |
| 20mg tadalafil | Other | Diagnostic Test: Endocan, Drug: tadalafil20 mg tadalafil |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with erectile dysfuction
Key exclusion criteria (3 listed)
- Psychogenic erectile dysfunction
- Erectile dysfunction associated with hormonal disorders
- Drug related 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EndocanEndocan will measured before and after treatment | Diagnostic test | 20mg tadalafil, 5mg tadalafil |
| tadalafiltadalafil | Drug | 20mg tadalafil, 5mg tadalafil |
Primary outcome
Rates of IIEF Score
Time frame: 1 month
Levels of Endocan relationship with IIEF
1 secondary outcome
Levels of Endocan
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
- Individual participant dataSharing planned: No. Research data
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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.
Veysel Bayburtluoğlu principal investigator
Ministry of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endocan and tadalafil in people with Erectile Dysfunction, run by Ankara Training and Research 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 1 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: status not confirmed, as of the sponsor's last update on 5 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Veysel Bayburtluoğlu (+905530299981, bayburtluogluveysel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of IIEF Score (time frame: 1 month). 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 5 Nov 2021; AzTrials last refreshed its copy on 31 Oct 2026.