NCT04100759 is a Phase 1, PHASE2 clinical trial of Sildenafil 50 mg Oral Tablet in Erectile Dysfunction, sponsored by Ain Shams University.

Who is sponsoring NCT04100759?

NCT04100759 is sponsored by Ain Shams University.

What drugs are being tested in NCT04100759?

Interventions in NCT04100759: Sildenafil 50 mg Oral Tablet.

What condition does NCT04100759 study?

NCT04100759 studies Erectile Dysfunction, Smoking, Pharmacokinetics, Pharmacodynamics.

Is NCT04100759 still recruiting?

NCT04100759 is currently completed. Last updated 24 September 2019.

Last reviewed 2019-09-24 · How we verify

NCT04100759

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1, PHASE2 Last updated 24 September 2019

What this trial tests

Phase 1, PHASE2 trial testing Sildenafil 50 mg Oral Tablet in Erectile Dysfunction in 36 participants. Completed in 8 July 2019.

Timeline

11 June 2019

Primary endpoint
25 June 2019

8 July 2019

Quick facts

Lead sponsor	Ain Shams University
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	36
Start date	11 June 2019
Primary completion	25 June 2019
Estimated completion	8 July 2019
Sites	1 location across Egypt

Drugs / interventions tested

Sildenafil 50 mg Oral Tablet

Conditions studied

Erectile Dysfunction — all drugs for Erectile Dysfunction →
Smoking — all drugs for Smoking →
Pharmacokinetics — all drugs for Pharmacokinetics →
Pharmacodynamics — all drugs for Pharmacodynamics →

Sponsor

Ain Shams University

Who can join

18 and older, male only, with Erectile Dysfunction or Smoking. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Changes in the Pharmacokinetics and Pharmacodynamics of Sildenafil in Cigarette and Cannabis Smokers.
Murtadha M, Raslan MA, Fahmy SF, Sabri NA. · · 2021 · cited 7× · PMID 34199328 · DOI 10.3390/pharmaceutics13060876

Verify or expand the search:

Other trials of Sildenafil 50 mg Oral Tablet

Trials testing the same drug.

NCT06522854 — Oral Sildenafil Citrate to Improve Maternal and Neonatal Outcomes in Low-resource Settings · Phase 3 · withdrawn
NCT06377098 — Intrapartum Sildenafil in Laboring Mothers · Phase 3 · withdrawn

Other recruiting trials for Erectile Dysfunction

Currently open trials in the same condition.

NCT07442396 — The Effectiveness of Exercise in the Treatment of Erectile Dysfunction and Premature Ejaculation · NA · recruiting
NCT07366970 — Is There a Benefit From Addition of Exercise in Diabetic Patients With ED Who Complain Low Vitamin D? · NA · recruiting
NCT06960746 — Changing Lifestyle in OSA Males Who Suffer Metabolic Syndrome and Impotence: Is There a Response? · NA · recruiting
NCT06872866 — The Objective of This Phase 1 Study is to Evaluate the Food Effect of 100 mg Hezkue Turbo® (ASP-001.1, Sildenafil) Under · Phase 1 · recruiting
NCT06805513 — Actual Use Trial of Tadalafil 5 mg · Phase 3 · recruiting

Other Ain Shams University trials

Trials by the same sponsor.

NCT07435493 — Fentanyl Versus Opioid Free Multimodal Analgesia for Perioperative Pain Control in Children With Mild to Moderate Obstru · NA · not yet recruiting
NCT07482540 — Role of Dexmedatomidine Drug in Prevention of Atrial Fibrillations Post Mitral Valve Surgery · NA · not yet recruiting
NCT07531030 — Posterior Pericapsular Deep Gluteal Block Combined With Pericapsular Nerve Group and Lateral Femoral Cutaneous Nerve Blo · NA · not yet recruiting
NCT06839027 — Arterial to Central co2gap in Relation to Outcome After Cardiopulmonary Bypass · not yet recruiting
NCT07516535 — DISS vs FANS in Suction-Assisted RIRS for Medium-Sized Renal Stones · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04100759 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ain Shams University
Last refreshed: 24 September 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04100759.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing