A Multi-center, Prospective, Randomized, Double-blind, Flexible-dose, Placebo-controlled, Parallel Group Clinical Trial of Sildenafil Oral Film 25 mg, 50 mg, 75 mg and 100 mg for the Treatment of Erectile Dysfunction (ED)
Abstract
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).
Conditions: Erectile Dysfunction.
Primary outcome: Safety of Sildenafil doses versus placebo; Efficacy of Sildenafil doses versus placebo - IIEF-EF; Efficacy of Sildenafil doses versus placebo - SEP Question 2; Efficacy of Sildenafil doses versus placebo - SEP Question 3.
Enrollment: 488 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 488 participants or records.
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