drugset / Trial / NCT05490680
A New Sildenafil Oral Film in Patients With Erectile Dysfunction
RandomizedParallel-groupDouble-blindTreatment
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).
Timeline
- Start
- 2024-01-26
- Primary completion
- 2024-12-09
- Completion
- 2024-12-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sildenafil | Unknown | 25 mg | Oral |
| Subject | Sildenafil | Unknown | 50 mg | Oral |
| Subject | Sildenafil | Unknown | 75 mg | Oral |
| Subject | Sildenafil | Unknown | 100 mg | Oral |