Sildenafil does not improve sexual function in men without erectile dysfunction but does reduce the postorgasmic refractory time N Mondaini 1,2 *, R Ponchietti 3 , GH Muir 2 , F Montorsi 4 , F Di Loro 1 , G Lombardi 1 and M Rizzo 1 1 Department of Urology, University of Florence, Italy; 2 Department of Urology, King’s College Hospital, London; 3 Department of Urology, University of Siena, Italy; and 4 Department of Urology, University Vita e Salute, San Raffaele, Milan, Italy Sildenafil is one of two oral drugs approved for first-line treatment of erectile dysfunction (ED). Anecdotally, some young healthy men who wish to enhance their sexual performance are requesting or abusing sildenafil. In this randomized double-blind, placebo-controlled clinical study, we investigated the effect of sildenafil in young men without ED. A total of 60 young healthy men age 20–40 y with no reported ED were enrolled for this single-dose home-use study. Subjects had used no medication in the 6 months prior to the study. All had been engaged in a stable relationship for at least 3 months. After completing the IIEF-5 questionnaire, patients were randomized in a double- blind fashion to receive either one 25 mg tablet of sildenafil (group 1) taken prior to intercourse, or an identical placebo tablet (group 2). All subjects completed a questionnaire relating to their erectile quality. There were no differences between the two groups in the reported improvement of erection quality, 12/30 sildenafil vs 10/30 placebo (Fisher’s test, P ¼ 0.79). Sildenafil caused a significant reduction of the postejaculatory refractory time (12/30 vs 4/30) (v 2 test, P ¼ 0.04). Sildenafil does not improve erections in young healthy men. Sildenafil should not be given to young healthy men to improve their erections and patients should be advised against recreational abuse of the drug. In this limited single-dose home study, sildenafil appears to reduce the postorgasmic refractory time. Although controlled studies are needed to evaluate the efficacy of erection-enhancing drugs in premature ejaculation, it is possible that sildenafil might be useful for this indication. International Journal of Impotence Research (2003) 15, 225–228. doi:10.1038/sj.ijir.3901005 Keywords: sildenafil; premature ejaculation; refractory time; IIEF; drug abuse Introduction and objectives Sildenafil is a specific inhibitor of phosphodiester- ase (PDE) type 5, and effective and well tolerated for erectile dysfunction (ED) of various etiologies. 1–3 Since sildenafil has no effect on libido and since healthy young men usually have good-quality erec- tions, there is no obvious reason to expect the drug to have a beneficial effect in young men without ED. However, due to media interest in the drug (often a so-called ‘lifestyle drug’), there seems to be a significant demand for sildenafil by young healthy males who wish to enhance sexual performance. 4 Anecdotal reports of serious events have included young men abusing sildenafil in combination with other sex-related drugs such as amyl nitrate, or in combination with ecstasy or cannabis. 5–6 The aim of our single-dose, home-use study was to investigate whether sildenafil improves erectile function in young healthy males. Material and methods In all, 92 young healthy men volunteers (age 20– 40 y) were evaluated at the Department of Urology of Florence with the International Index for Erectile Function Questionnaire (IIEF-5). 7,8 None reported ED, and only men whose IIEF-5 result in the range 26–30 (normal score) were eligible for our study. No subjects had used any medication in the 6- month period prior to the study. All had been Received 20 October 2002; revised 21 February 2003; accepted 2 March 2003 *Correspondence: Dr N Mondaini, Via Colleramole 8 Impruneta, Firenze 50029, Italy. E-mail: mondatre@hotmail.com International Journal of Impotence Research (2003) 15, 225–228 & 2003 Nature Publishing Group All rights reserved 0955-9930/03 $25.00 www.nature.com/ijir