A New Sildenafil Oral Film in Patients With Erectile Dysfunction

Completed · Phase 3 · Has a placebo group

Conditions studied: Erectile Dysfunction

In brief

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).

Key facts

Study ID

NCT05490680

Run by

IBSA Institut Biochimique SA

People needed

488

Starts

2024-01-26

Expected to finish

2024-12-09

Last updated by the study team

2025-10-23

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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