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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05446493
Other study ID # 346/3/19
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 1, 2019
Est. completion date January 5, 2022

Study information

Verified date July 2022
Source Aswan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date January 5, 2022
Est. primary completion date March 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 30 Years to 70 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tadalafil 5mg
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

Locations

Country Name City State
Egypt Aswan university Aswan

Sponsors (1)

Lead Sponsor Collaborator
Aswan University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 3 months
Secondary 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) 3 months
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