The study will consist of Screening & Pre-treatment phase (Visit 0 followed by 4 weeks without treatment for the subjects who met eligibility criteria at screening phase) and Double-blind Treatment Phase comprising a 12-week treatment period for the subjects who were compliant in pre-treatment phase (Visits 1, 2, 3 and 4).~The target population for this study is men with ED, including 30-35% of geriatric ED subjects. During the treatment period, subjects will be instructed to take 1 dose of Sildenafil oral film or Placebo approximately 60 minutes prior to initiation of sexual activity. The study foresees a fixed-dose regimen and no change in the assigned dosage can be made during the study. Study medication can be taken without water and in addition with or without food and no restrictions will be placed on the timing for consumption of food (details regarding type and time of food and alcohol intake will be collected).
This is a Phase III, prospective, interventional, multi-center, randomized, double-blind, fixed-dose, placebo-controlled, parallel group clinical study required by FDA to demonstrate the efficacy and safety of Sildenafil oral film 50 mg, 75 mg and 100 mg as compared to placebo in approximately 600 men clinically diagnosed with erectile dysfunction (ED).