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New dissolving film for ED shows promise in large trial

NCT ID NCT05490680

Symptom relief Sponsor: IBSA Institut Biochimique SA Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new oral film form of sildenafil (the active ingredient in Viagra) at doses from 25 mg to 100 mg in 488 men with erectile dysfunction (ED). The goal was to see if the film is safe and effective compared to a placebo. Participants took the film as needed before sexual activity, and researchers measured improvements in erection function and sexual encounters.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

488 people

The number who actually took part.

Started

Jan 2024

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Heterosexual male subjects aged ≥18 years; * Confirmed clinical diagnosis of ED for at least 6 months; * Involved in a continuous sexual relationship with their partner for at least 3 months. * Able and willing to provide voluntary written informed consent Exclusion Criteria: * Currently suffering from any oromucosal condition or recent oral surgery that could interfere with the study drug; * Any significant cardiovascular abnormality; * Patients ≥ 65 years with any degree of hepatic impairment or severe renal impairment or any significant pulmonary, gastrointestinal, hematological, endocrinal, metabolic or neurological disorder; * Patients \< 65 years with severe hepatic impairment; * Any presence of chronic indwelling urethral catheterization or penile anatomical abnormalities that would significantly impair EF; * Any history of Peyronie's disease; or who have conditions which may predispose them to priapism; * Any history or comorbidity of hypoactive sexual desire disorder, premature ejaculation or other ejaculatory disorders or radical prostatectomy; * Any history of severe/uncontrolled diabetes or radical prostatectomy or spinal cord injury * Hypersensitivity to Sildenafil or to any of the excipients of the oral film, or idiosyncratic reactions to other PDE5 inhibitors; * Any history of migraine; * Any history of complete unresponsiveness to PDE5 inhibitor treatment or significant side-effects with PDE5 inhibitor; * Subjects with or with history of severe vision impairment, temporary visual disturbances (blurred vision, increased light sensitivity and color change), retinitis pigmentosa, Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) or any optic neuropathy; * Subjects taking a strong CYP3A4 inhibitor(s); * During the course of the study, subjects are not allowed to take any prescription, over-the-counter, herbal, or naturopathic products for "male enhancement" or the treatment of ED; * During the course of the study, subjects are not allowed to take any form of nitric oxide donors such as organic nitrates or organic nitrites either regularly and/or intermittently, and guanylate cyclase (GC) stimulators; * Patients must be stable on therapy with Alpha-blockers or Amlodipine at inclusion and already taking a PDE5 inhibitor without any safety concern prior to initiating the study (i.e., no history of significant side-effects with co-administration of PDE5 inhibitors); * Subjects known to abuse alcohol or drugs that could interfere with the patient's safety or study compliance * Subjects who are illiterate or are unable to understand how to use eDiary and complete the questionnaires

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Conditions

The condition(s) this trial relates to.

erectile dysfunction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Erectile dysfunction

Contacts and locations

Locations

  • AccuMed Research Associates

    Garden City, New York, 11530, United States

  • Alliance for Multispecialty Research, LLC

    Las Vegas, Nevada, 89119, United States

  • Alliance for Multispeciaty Research, LLC

    Knoxville, Tennessee, 37909, United States

  • Arkansas Urology Research Center

    Little Rock, Arkansas, 72211, United States

  • Clintex Research Group

    Miami, Florida, 33135, United States

  • Coral Research Clinic

    Miami, Florida, 33186, United States

  • G & L Research LLC.

    Foley, Alabama, 36535, United States

  • Harmony Clinical Research

    North Miami Beach, Florida, 33162, United States

  • Innovation Clinical Trials: Medical Reseach Center

    Palmetto Bay, Florida, 33157, United States

  • Innovation Medical Group LLC (Endo Care of South Florida)

    Fort Lauderdale, Florida, 33316, United States

  • Medical Affiliated Research Center

    Huntsville, Alabama, 35801, United States

  • Mt. Olympus Medical Research Group, LLC

    Sugar Land, Texas, 77479, United States

  • Precision Clinical Research, LLC

    Sunrise, Florida, 33351, United States

  • Rochester Clinical Research, Inc

    Rochester, New York, 14609, United States

  • Tranquil Clinical and Research Consulting Services, LLC

    Webster, Texas, 77598, United States

  • Tri Valley Urology Medical Group

    Murrieta, California, 92562, United States

  • Urology Group of Southern California

    Los Angeles, California, 90017, United States

  • Virginia Urology

    Richmond, Virginia, 23235, United States

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