Back to resultsSerum YKL-40 Level and Platelets Indices Among Patients With Diabetic Erectile Dysfunction
Primary Purpose
Erectile Dysfunction, Erectile Dysfunction With Diabetes Mellitus
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Tadalafil 5mg
Sponsored by
About this trial
This is an interventional diagnostic trial for Erectile Dysfunction
Eligibility Criteria
Inclusion Criteria:
- Diabetic patients with ED.
Exclusion Criteria:
- Patients with history of pelvic trauma.
- Patients with major pelvic surgical intervention.
- Patients with hypogonadism and hyperprolactinemia.
- Patients with chronic liver disease.
- Patients with cardio vascular system diseases.
- History of chronic intake of central nervous system, anti androgen drugs or other drugs as Tramadol.
- Smokers patients.
- Patients with non-vasculogenic Erectile dysfunction.
Sites / Locations
- Aswan university
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Tadalafil group
control group
Arm Description
Each patient will be treated by tadalafil 5mg daily for 3months
Estimation of serum YKL-40, platelet indices and serum total testosterone in healthy individuals in camparing with tadalafil group
Outcomes
Primary Outcome Measures
Serum YKL-40 and platelets indices in erectile dysfunction
Measurement of YKL-40 and platelets indices in diabetic patients with erectile dysfunction treated by daily tadalafil.
Secondary Outcome Measures
Effect of tadalafil on Erectile dysfucntion patients
To show the therapeutic effect of tadalafil in dose 5 mg daily on Erectile dysfucntion patients and assess their response by international index of erectile function (IIEF-5)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05446493
Brief Title
Serum YKL-40 Level and Platelets Indices Among Patients With Diabetic Erectile Dysfunction
Official Title
Assessment of Serum YKL-40 Level and Platelets Indices Among Patients With Diabetic Erectile Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
March 15, 2021 (Actual)
Study Completion Date
January 5, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aswan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this current study is to estimate serum level of YKL-40, serum total testosterone and platelets indices in diabetic patients with erectile dysfunction treated by daily tadalafil 5mg for 3 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction, Erectile Dysfunction With Diabetes Mellitus
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tadalafil group
Arm Type
Active Comparator
Arm Description
Each patient will be treated by tadalafil 5mg daily for 3months
Arm Title
control group
Arm Type
No Intervention
Arm Description
Estimation of serum YKL-40, platelet indices and serum total testosterone in healthy individuals in camparing with tadalafil group
Intervention Type
Drug
Intervention Name(s)
Tadalafil 5mg
Intervention Description
Estimate serum level of serum YKL-40, total testosterone and platelets indices in diabetic patients with erectile dysfunction treated by daily tadalafil 5mg for 3months.
Penile color Doppler ultrasound examination before and after treatment
Primary Outcome Measure Information:
Title
Serum YKL-40 and platelets indices in erectile dysfunction
Description
Measurement of YKL-40 and platelets indices in diabetic patients with erectile dysfunction treated by daily tadalafil.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Effect of tadalafil on Erectile dysfucntion patients
Description
To show the therapeutic effect of tadalafil in dose 5 mg daily on Erectile dysfucntion patients and assess their response by international index of erectile function (IIEF-5)
Time Frame
3 months
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Diabetic patients with ED.
Exclusion Criteria:
Patients with history of pelvic trauma.
Patients with major pelvic surgical intervention.
Patients with hypogonadism and hyperprolactinemia.
Patients with chronic liver disease.
Patients with cardio vascular system diseases.
History of chronic intake of central nervous system, anti androgen drugs or other drugs as Tramadol.
Smokers patients.
Patients with non-vasculogenic Erectile dysfunction.
Facility Information:
Facility Name
Aswan university
City
Aswan
ZIP/Postal Code
81528
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Serum YKL-40 Level and Platelets Indices Among Patients With Diabetic Erectile Dysfunction
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