NCT05490680

A New Sildenafil Oral Film in Patients With Erectile Dysfunction

A Multi-center, Prospective, Randomized, Double-blind, Flexible-dose, Placebo-controlled, Parallel Group Clinical Trial of Sildenafil Oral Film 25 mg, 50 mg, 75 mg and 100 mg for the Treatment of Erectile Dysfunction (ED)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 488 (actual)
• Sponsor: IBSA Institut Biochimique SA · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase III, prospective, interventional, multi-center, randomized, double-blind, flexible-dose, placebo-controlled, parallel group clinical study required by FDA to demonstrate the efficacy and safety of Sildenafil oral film 25 mg, 50 mg, 75 mg and 100 mg as compared to placebo in approximately 488 men clinically diagnosed with erectile dysfunction (ED).

Detailed description

The study will consist of a Screening Visit (Visit 0) followed by a 4-week run-in period without treatment and by a Randomization Visit (Visit 1) for the subjects who were compliant in pre-treatment phase. After randomization, the subject will start a 12-week, double-blind, flexible-dose, treatment phase comprising 4 at Site Visits performed 2 weeks after starting the treatment (Visit 2), after additional 2 weeks (Visit 3) and every 4 weeks (Visits 4 and 5) until the End of Study. The target population for this study is men with ED, including 30-35% of geriatric ED subjects. Subjects \< 65 years of age will be randomized to receive the Sildenafil/Placebo oral film at 50 mg dose. Subjects ≥ 65 years of age will be randomized to receive the Sildenafil/Placebo oral film at 25 mg dose. The study foresees a flexible-dose regimen and the starting dosage can be increased to 50 mg (for subjects ≥ 65 years of age), 75 mg or 100 mg dosage, or decreased.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	Sildenafil Oral Film 25 mg, 50 mg, 75 mg or 100 mg	Sildenafil Oral Film containing 25 mg, 50 mg, 75 mg or 100 mg sildenafil as citrate, flexible-dose
DRUG	Placebo	Placebo Oral Film

Timeline

• Start date: 2024-01-26
• Primary completion: 2024-12-09
• Completion: 2024-12-09
• First posted: 2022-08-08
• Last updated: 2025-10-23

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study