Endocan Level in Patients With Erectile Dysfunction and Relationship With Tadalafil Treatment
Primary Purpose
Erectile Dysfunction
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Endocan
tadalafil
Sponsored by
About this trial
This is an interventional diagnostic trial for Erectile Dysfunction focused on measuring Endocan, Erectile dysfunction, Tadalafil
Eligibility Criteria
Inclusion Criteria:
• Patients with erectile dysfuction
Exclusion Criteria:
- Psychogenic erectile dysfunction
- Erectile dysfunction associated with hormonal disorders
- Drug related erectile dysfunction
Sites / Locations
- Veysel BayburtluoğluRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
5mg tadalafil
20mg tadalafil
Arm Description
5mg tadalafil
20 mg tadalafil
Outcomes
Primary Outcome Measures
Rates of IIEF Score
Levels of Endocan relationship with IIEF
Secondary Outcome Measures
Levels of Endocan
Levels of Endocan with tadalafil treatment
Full Information
NCT ID
NCT05109377
First Posted
September 4, 2021
Last Updated
November 4, 2021
Sponsor
Ankara Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05109377
Brief Title
Endocan Level in Patients With Erectile Dysfunction and Relationship With Tadalafil Treatment
Official Title
Endocan Level in Patients With Erectile Dysfunction and Relationship With Tadalafil Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 24, 2021 (Actual)
Primary Completion Date
November 15, 2021 (Anticipated)
Study Completion Date
December 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
Endocan, Erectile dysfunction, Tadalafil
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
5mg tadalafil
Arm Type
Other
Arm Description
5mg tadalafil
Arm Title
20mg tadalafil
Arm Type
Other
Arm Description
20 mg tadalafil
Intervention Type
Diagnostic Test
Intervention Name(s)
Endocan
Intervention Description
Endocan will measured before and after treatment
Intervention Type
Drug
Intervention Name(s)
tadalafil
Intervention Description
tadalafil
Primary Outcome Measure Information:
Title
Rates of IIEF Score
Description
Levels of Endocan relationship with IIEF
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Levels of Endocan
Description
Levels of Endocan with tadalafil treatment
Time Frame
1 month
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
• Patients with erectile dysfuction
Exclusion Criteria:
Psychogenic erectile dysfunction
Erectile dysfunction associated with hormonal disorders
Drug related erectile dysfunction
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Veysel Bayburtluoğlu
Phone
+905530299981
Email
bayburtluogluveysel@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veysel Bayburtluoğlu
Organizational Affiliation
Ministry of Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Veysel Bayburtluoğlu
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Veysel Bayburtluoğlu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Research data
Learn more about this trial
Endocan Level in Patients With Erectile Dysfunction and Relationship With Tadalafil Treatment
We'll reach out to this number within 24 hrs