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

Sponsor
Aswan University (Other)
Overall Status
Completed
CT.gov ID
NCT05446493
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
33.2
Actual Duration (Months)
1.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tadalafil 5mg
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Assessment of Serum YKL-40 Level and Platelets Indices Among Patients With Diabetic Erectile Dysfunction
Actual Study Start Date :
Apr 1, 2019
Actual Primary Completion Date :
Mar 15, 2021
Actual Study Completion Date :
Jan 5, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Serum YKL-40 and platelets indices in erectile dysfunction [3 months]

    Measurement of YKL-40 and platelets indices in diabetic patients with erectile dysfunction treated by daily tadalafil.

Secondary Outcome Measures

  1. Effect of tadalafil on Erectile dysfucntion patients [3 months]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 70 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aswan university Aswan Egypt 81528

Sponsors and Collaborators

  • Aswan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohamed Amer Ahmed Abdellatif, Assistant lecturer, Aswan University
ClinicalTrials.gov Identifier:
NCT05446493
Other Study ID Numbers:
  • 346/3/19
First Posted:
Jul 6, 2022
Last Update Posted:
Jul 6, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Erectile Dysfunction
Tadalafil

Study Results

No Results Posted as of Jul 6, 2022