a phase 3, placebo controlled study of the safety and efficacy of avanafil for the treatment of erectile dysfunction after nerve sparing radical prostatectomy：阶段3，安慰剂对照研究的安全性和疗效avanafil治疗勃起功能障碍保留神经的根治性前列腺切除术后.pdf

A Phase 3, Placebo Controlled Study of the Safety and Efficacy of Avanafil for the Treatment of Erectile Dysfunction After Nerve Sparing Radical Prostatectomy John P. Mulhall,*,† Arthur L. Burnett,‡ Run Wang,§ Kevin T. McVary, Judd W. Moul,¶ Charles H. Bowden,** Karen DiDonato,** Winnie Shih** and Wesley W. Day** From Memorial Sloan-Kettering Cancer Center, New York, New York (JPM), The Johns Hopkins Medical Institutions, Baltimore, Maryland (ALB), University of Texas Medical School at Houston and MD Anderson Cancer Center, Houston, Texas (RW), Northwestern University/Feinberg School of Medicine, Chicago, Illinois (KTM), Division of Urology, Department of Surgery and Duke Cancer Institute, Durham, North Carolina (JWM), and VIVUS, Inc., Mountain View, California (CHB, KD, WS, WWD) Purpose: We evaluated the safety and efficacy of 100 and 200 mg avanafil for the Abbreviations treatment of adult males with erectile dysfunction after bilateral nerve sparing and Acronyms radical prostatectomy. AE adverse event Materials and Methods: This was a double-blind, placebo controlled, parallel ED erectile dysfunction group, phase 3 study in males age 18 to 70 years with a history of erectile EF erectile function dysfunction of 6 months or more after bilateral nerve sparing radical prostatec- tomy. Patients were randomized to 100 or 200 mg avanafil or placebo (taken 30 IIEF International Index of minutes before sexual activity) for 12 weeks. Primary end points included suc-