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A New Sildenafil Oral Film in Patients With Erectile Dysfunction

NCT05490680 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 488

Last updated 2025-10-23

No results posted yet for this study

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).

Conditions

Interventions

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

Sponsors & Collaborators

  • IBSA Institut Biochimique SA

    lead INDUSTRY

Principal Investigators

  • Mitchell D. Efros, MD · Accumed Research Associates

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-26
Primary Completion
2024-12-09
Completion
2024-12-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05490680 on ClinicalTrials.gov