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The British Journal of Psychiatry (2001) 178: 325-330
© 2001 The Royal College of Psychiatrists

Efficacy and safety of sildenafil citrate in the treatment of men with mild to moderate erectile dysfunction

IAN EARDLEY, FRCS

Department of Urology, Leeds General Infirmary, Leeds

ROBERT MORGAN, FRCS

Royal Free Hospital, London

WALLACE DINSMORE, FRCP

Genito-Urinary Medicine Department, Royal Victoria Hospital, Belfast

PAULA YATES, PhD and MITRADEV BOOLELL, MD

Pfizer Ltd, Sandwich, Kent

Correspondence: Ian Eardley, Department of Urology, Leeds General Infirmary, Leeds LSI 3EX. Tel: 01132 923561; Fax: 01132 926347

Declaration of interest Research supported by Pfizer Inc.

Background Erectile dysfunction is a common, multi-factorial disorder.

Aims To evaluate the efficacy, tolerability and frequency of use of sildenafil citrate in men with mild to moderate erectile dysfunction of no established organic cause.

Method This double-blind, randomised, placebo-controlled, flexible-dose, two-way crossover study was conducted at four centres in the UK in 44 men with mild to moderate erectile dysfunction of no clinically obvious organic cause. The study included two 28-day treatment periods, during which time sildenafil or placebo (25-75 mg, based on efficacy) was taken as required.

Results Compared with placebo, sildenafil was associated with increases in frequency of use, erections adequate for sexual intercourse and level of sexual satisfaction (P<0.0001). More patients receiving sildenafil stated they would use the treatment again compared with those receiving placebo (P<0.0001). There were no discontinuations due to sildenafil treatment.

Conclusions Sildenafil is effective and well tolerated in men with mild to moderate erectile dysfunction of no clinically identifiable organic cause.




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