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NCT05490680

A New Sildenafil Oral Film in Patients With Erectile Dysfunction

A Multi-center, Prospective, Randomized, Double-blind, Fixed-dose, Placebo-controlled, Parallel Group Clinical Trial of Sildenafil Oral Film 50 mg, 75 mg and 100 mg for the Treatment of Erectile Dysfunction (ED)
IBSA Institut Biochimique SA·Phase 3·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Erectile Dysfunction
Drug/Device/Intervention
Sildenafil Oral Film 50 mg
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
IBSA Institut Biochimique SA
Timeline & enrollment
Phase
Phase 3
Start date
Nov 01, 2022
End date
Aug 01, 2023
Enrollment
600 participants
Primary outcome

Safety of Sildenafil doses versus placebo,Efficacy of Sildenafil 50 mg doses versus placebo - IIEF-EF,Efficacy of Sildenafil 75 mg doses versus placebo - IIEF-EF,Efficacy of Sildenafil 100 mg doses versus placebo - IIEF-EF,Efficacy of Sildenafil 50 mg doses versus placebo - SEP Question 2,Efficacy of Sildenafil 75 mg doses versus placebo - SEP Question 2,Efficacy of Sildenafil 100 mg doses versus placebo - SEP Question 2,Efficacy of Sildenafil 50 mg doses versus placebo - SEP Question 3,Efficacy of Sildenafil 75 mg doses versus placebo - SEP Question 3,Efficacy of Sildenafil 100 mg doses versus placebo - SEP Question 3

Summary

This is a Phase III, prospective, interventional, multi-center, randomized, double-blind,
 fixed-dose, placebo-controlled, parallel group clinical study required by FDA to demonstrate
 the efficacy and safety of Sildenafil oral film 50 mg, 75 mg and 100 mg as compared to
 placebo in approximately 600 men clinically diagnosed with erectile dysfunction (ED).

ICD-10 classifications
Orgasmic dysfunctionOther disorders of penisOther specified disorders of penisSexual dysfunction, not caused by organic disorder or diseaseTesticular dysfunction
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05490680
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05490680 through Pure Global AI's free database. This Phase 3 trial is sponsored by IBSA Institut Biochimique SA and is currently Not yet recruiting. The study focuses on Erectile Dysfunction. Target enrollment is 600 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.