Oral Sildenafil in the Treatment of Erectile Dysfunction

This chapter summarizes the results of a landmark trial comparing different doses of oral sildenafil versus placebo to treat erectile dysfunction. Patients received either an identical placebo or 25- mg, 50-mg, or 100-mg tablets of sildenafil to be taken approximately one hour before planned sexual activity (but not more than once daily) for 24 weeks. Higher doses of sildenafil resulted in higher mean score for frequency of penetration and maintenance of erection, which were also consistently better than placebo. The most common side effects were headaches, flushing, dyspepsia, rhinitis, and visual disturbances. This study established sildenafil as an effective, reasonably well-tolerated treatment for men with erectile dysfunction of varying etiologies.