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 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 …