A New Sildenafil Oral Film in Patients With Erectile Dysfunction

The study will consist of a Screening Visit (Visit 0) followed by a 4-week run-in period without treatment and by a Randomization Visit (Visit 1) for the subjects who were compliant in pre-treatment phase. After randomization, the subject will start a 12-week, double-blind, flexible-dose, treatment phase comprising 4 at Site Visits performed 2 weeks after starting the treatment (Visit 2), after additional 2 weeks (Visit 3) and every 4 weeks (Visits 4 and 5) until the End of Study.

The target population for this study is men with ED, including 30-35% of geriatric ED subjects. Subjects < 65 years of age will be randomized to receive the Sildenafil/Placebo oral film at 50 mg dose. Subjects ≥ 65 years of age will be randomized to receive the Sildenafil/Placebo oral film at 25 mg dose. The study foresees a flexible-dose regimen and the starting dosage can be increased to 50 mg (for subjects ≥ 65 years of age), 75 mg or 100 mg dosage, or decreased.

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