Endocan Level in Patients With Erectile Dysfunction and R... | NCT05109377

Studies
Endocan Level in Patients With Erectile Dysfunction and Relationship With Tadalafil Treatment

NCT05109377

Sponsor

Ankara Training and Research Hospital

Status

Unknown status

Last Update Posted

Nov 5, 2021Actual

Enrollment

90Estimated

Phase

Not Applicable

Conditions

Erectile Dysfunction

Interventions

Endocan
tadalafil

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 24, 2021Actual

Primary Completion Date

Nov 15, 2021Estimated

Completion Date

Dec 15, 2021Estimated

First Submitted Date

Sep 4, 2021

First Submission Date that Met QC Criteria

Nov 4, 2021

First Posted Date

Nov 5, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 4, 2021

Last Update Posted Date

Nov 5, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Veysel Bayburtluoğlu, Principal Investigator, Ankara Training and Research HospitalPrincipal Investigator

Lead Sponsor

Ankara Training and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
5mg tadalafil	Other	5mg tadalafil	Diagnostic Test: Endocan Drug: tadalafil
20mg tadalafil	Other	20 mg tadalafil	Diagnostic Test: Endocan Drug: tadalafil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endocan	Diagnostic Test	Endocan will measured before and after treatment	20mg tadalafil 5mg tadalafil

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rates of IIEF Score	Levels of Endocan relationship with IIEF	1 month

Secondary Outcomes

Measure	Description	Time Frame
Levels of Endocan	Levels of Endocan with tadalafil treatment	1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

• Patients with erectile dysfuction

Exclusion Criteria:

Psychogenic erectile dysfunction
Erectile dysfunction associated with hormonal disorders
Drug related erectile dysfunction

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Veysel Bayburtluoğlu	Contact	+905530299981		bayburtluogluveysel@gmail.com

Overall Officials

Name	Affiliation	Role
Veysel Bayburtluoğlu	Ministry of Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Veysel Bayburtluoğlu	Recruiting	Ankara			Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Research data

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007172	Erectile Dysfunction

Ancestor Terms

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D012735	Sexual Dysfunction, Physiological

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068581	Tadalafil

Ancestor Terms

ID	Term
D002243	Carbolines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided