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A Comparative Pharmacokinetic and Pharmacodynamic Study of Sildenafil in Adult Smokers and Non Smokers

NCT04100759 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2019-09-24

No results posted yet for this study

Summary

Smokers are at higher risk of developing Erectile dysfunction (ED) independent of age and comorbidities. Sildenafil is a cytochrome p3A4 (CYP3A4) substrate used for enhancing the erectile function in males. The study purpose is to determine the effect of smoking on male sexual function based on the international index of erectile function score (IIEF) and investigate the effect of smoking (Cigarettes or marijuana) on the pharmacokinetics and pharmacodynamics of sildenafil.

Conditions

Interventions

DRUG

Sildenafil 50 mg Oral Tablet

Sildenafil 50 mg Oral Tablet

Sponsors & Collaborators

  • Drug Research Centre, Cairo, Egypt

    collaborator OTHER

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Nagwa A Sabri, phD · Ainshams university

  • Mohammed M Hussein, Msc student · Ainshams university

  • Mohamed A Raslan · Drug Research Centre, Cairo, Egypt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-11
Primary Completion
2019-06-25
Completion
2019-07-08

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04100759 on ClinicalTrials.gov