Serum YKL-40 Level and Platelets Indices Among Patients With Diabetic Erectile Dysfunction

Assessment of Serum YKL-40 Level and Platelets Indices Among Patients With Diabetic Erectile Dysfunction

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.

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction; Erectile Dysfunction With Diabetes Mellitus
• Intervention / Treatment: Drug: Tadalafil 5mg

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Aswan, Egypt, 81528
    • Aswan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tadalafil group; Each patient will be treated by tadalafil 5mg daily for 3months	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
No Intervention: control group; Estimation of serum YKL-40, platelet indices and serum total testosterone in healthy individuals in camparing with tadalafil group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Aswan University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): March 15, 2021
• Study Completion (Actual): January 5, 2022

Study Registration Dates

• First Submitted: January 5, 2022
• First Submitted That Met QC Criteria: July 5, 2022
• First Posted (Actual): July 6, 2022

Study Record Updates

• Last Update Posted (Actual): July 6, 2022
• Last Update Submitted That Met QC Criteria: July 5, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Tadalafil
• Other Study ID Numbers: 346/3/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No