Clinical trialNCT05490680CompletedPhase 3Interventional

A New Sildenafil Oral Film in Patients With Erectile Dysfunction

SponsorIBSA Institut Biochimique SAEnrollment488Erectile Dysfunction

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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).

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Mitchell D. Efros, MD
Accumed Research Associates
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

18 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

G & L Research Llc.
Foley, Alabama, United States
Medical Affiliated Research Center
Huntsville, Alabama, United States
Arkansas Urology Research Center
Little Rock, Arkansas, United States
Urology Group of Southern California
Los Angeles, California, United States
Tri Valley Urology Medical Group
Murrieta, California, United States
Innovation Medical Group Llc (endo Care of South Florida)
Fort Lauderdale, Florida, United States
Clintex Research Group
Miami, Florida, United States
Coral Research Clinic
Miami, Florida, United States
Harmony Clinical Research
North Miami Beach, Florida, United States
Innovation Clinical Trials: Medical Reseach Center
Palmetto Bay, Florida, United States
Precision Clinical Research, Llc
Sunrise, Florida, United States
Alliance for Multispecialty Research, Llc
Las Vegas, Nevada, United States
Accumed Research Associates
Garden City, New York, United States
Rochester Clinical Research, Inc
Rochester, New York, United States
Alliance for Multispeciaty Research, Llc
Knoxville, Tennessee, United States
Mt. Olympus Medical Research Group, Llc
Sugar Land, Texas, United States
Tranquil Clinical and Research Consulting Services, Llc
Webster, Texas, United States
Virginia Urology
Richmond, Virginia, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

PlaceboSildenafil Oral Film 25 mg, 50 mg, 75 mg or 100 mg

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 26 Jan 2024
Primary completion: 9 Dec 2024
Completion: 9 Dec 2024
Last update posted: 23 Oct 2025
Registered enrollment: 488
Registry id: NCT05490680

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.