A New Sildenafil Oral Film in Patients with Erectile Dysfunction

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 3months.

• Able and willing to provide voluntary written informed consent

Exclusion Criteria:

• Currently suffering from any oromucosal condition or recent oral surgery that couldinterfere with the study drug;

• Any significant cardiovascular abnormality;

• Patients ≥ 65 years with any degree of hepatic impairment or severe renal impairmentor any significant pulmonary, gastrointestinal, hematological, endocrinal, metabolicor neurological disorder;

• Patients < 65 years with severe hepatic impairment;

• Any presence of chronic indwelling urethral catheterization or penile anatomicalabnormalities that would significantly impair EF;

• Any history of Peyronie's disease; or who have conditions which may predispose themto priapism;

• Any history or comorbidity of hypoactive sexual desire disorder, prematureejaculation or other ejaculatory disorders or radical prostatectomy;

• Any history of severe/uncontrolled diabetes or radical prostatectomy or spinal cordinjury

• Hypersensitivity to Sildenafil or to any of the excipients of the oral film, oridiosyncratic reactions to other PDE5 inhibitors;

• Any history of migraine;

• Any history of complete unresponsiveness to PDE5 inhibitor treatment or significantside-effects with PDE5 inhibitor;

• Subjects with or with history of severe vision impairment, temporary visualdisturbances (blurred vision, increased light sensitivity and color change),retinitis pigmentosa, Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) orany 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 thetreatment of ED;

• During the course of the study, subjects are not allowed to take any form of nitricoxide donors such as organic nitrates or organic nitrites either regularly and/orintermittently, and guanylate cyclase (GC) stimulators;

• Patients must be stable on therapy with Alpha-blockers or Amlodipine at inclusionand already taking a PDE5 inhibitor without any safety concern prior to initiatingthe study (i.e., no history of significant side-effects with co-administration ofPDE5 inhibitors);

• Subjects known to abuse alcohol or drugs that could interfere with the patient'ssafety or study compliance

• Subjects who are illiterate or are unable to understand how to use eDiary andcomplete the questionnaires