EFFICACY AND SAFETY OF ORAL SILDENAFIL IN THE TREATMENT OF ERECTILE DYSFUNCTION: A DOUBLE‐BLIND, PLACEBO‐CONTROLLED STUDY OF 329 PATIENTS

SUMMARY The efficacy and safety of oral sildenafil citrate for the treatment of erectile dysfunction (ED) were assessed in a 12‐week placebo‐controlled study. Men with ED of organic, psychogenic, or mixed aetiology were randomised to placebo (n=166) or 50 mg sildenafil (n=163), with adjustment to 100 mg or 25 mg based on efficacy and tolerability. Efficacy assessments included a global efficacy question, event log data, and an optional partner questionnaire. At the end of the study, improved erections were reported by 74% of patients receiving sildenafil versus 16% for placebo (p