A New Sildenafil Oral Film in Patients With Erectile Dysfunction - Trial NCT05490680
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.
Study Focus
Sponsor & Location
IBSA Institut Biochimique SA
Timeline & Enrollment
Phase 3
Nov 01, 2022
Aug 01, 2023
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
Data Source
ClinicalTrials.gov
NCT05490680
Non-Device Trial