© 1998 Evidence-Based Mental Health
Sildenafil improved sexual function in erectile dysfunction
Goldstein I, Lue TF, Padma-Nathan H, et al, for the Sildenafil Study Group. Oral sildenafil in the treatment of erectile dysfunction.N Engl J Med 1998 May 14;338:1397–404
Question In men with erectile dysfunction, is sildenafil (Viagra) effective in improving erectile function and increasing the rate of successful attempts at sexual intercourse?
2 randomised, double blind, placebo controlled trials with 24 weeks follow up for the dose response study and 12 weeks follow up for the dose escalation study.
37 centres in the US.
861 men (mean age 58 y) who had erectile dysfunction lasting 
6 months and were in a stable relationship with a female partner for 6 months. Exclusion criteria were penile anatomical defects, another sexual disorder, spinal cord injury, major psychiatric disorder not well controlled with treatment, poorly controlled diabetes mellitus, peptic ulcer disease, history of alcohol or substance abuse, major systemic abnormalities, recent stroke or myocardial infarction, or receipt of nitrate therapy. 87% of men completed the dose response study and 93% completed the dose escalation study.
Dose response study: men were allocated to placebo (n=216) or to 25, 50, or 100 mg of sildenafil (n=316). Dose escalation study: men were allocated to placebo (n=166) or to 50
Kinsey Institute, Indiana University Bloomington, Indiana, USA
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