Oral sildenafil in the treatment of erectile dysfunction. Sildenafil Study Group
Abstract
No AccessJournal of Urology1 Feb 2002Oral sildenafil in the treatment of erectile dysfunction Irwin Goldstein, M.D. Tom F. Lue, M.D. Harin Padma-Nathan, M.D. Raymond C. Rosen, Ph.D. William D. Steers, M.D. Pierre A. Wicker, andM.D. Sildenafil Study Group Irwin GoldsteinIrwin Goldstein , Tom F. LueTom F. Lue , Harin Padma-NathanHarin Padma-Nathan , Raymond C. RosenRaymond C. Rosen , William D. SteersWilliam D. Steers , Pierre A. WickerPierre A. Wicker , and Sildenafil Study Group View All Author Informationhttps://doi.org/10.1016/S0022-5347(02)80386-XAboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Background Sildenafil is a potent inhibitor of cyclic guanosine monophosphate in the corpus cavernosum and therefore increases the penile response to sexual stimulation. We evaluated the efficacy and safety of sildenafil, administered as needed in two sequential double-blind studies of men with erectile dysfunction of organic, psychogenic, or mixed causes. Methods In a 24-week dose-response study, 532 men were treated with oral sildenaffi (25, 50, or 100 mg) or placebo. In a 12-week, flexible dose-escalation study, 329 different men were treated with sildenafil or placebo, with dose escalation to 100 mg based on efficacy and tolerance. After this doseescalation study, 225 of the 329 men entered a 32-week, open-label extension study. We assessed efficacy according to the International Index of Erectile Function, a…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 532 participants or records.
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