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Safety and Efficacy of Once Daily Administration of 50 mg Mirodenafil in Patients with Erectile Dysfunction: a Multicenter, Double-Blind, Placebo Controlled Trial

2012; Lippincott Williams & Wilkins; Volume: 189; Issue: 3 Linguagem: Inglês

10.1016/j.juro.2012.08.243

1527-3792

Jae Hoon Chung, Dong Hyuk Kang, Cheol Young Oh, Jae Min Chung, Ki Soo Lee, Tae Hyo Kim, Kyung Hyun Moon, Wan Lee, Jeong Man Cho, Seung Wook Lee,

Sexual Differentiation and Disorders

No AccessJournal of UrologyAdult Urology1 Mar 2013Safety and Efficacy of Once Daily Administration of 50 mg Mirodenafil in Patients with Erectile Dysfunction: a Multicenter, Double-Blind, Placebo Controlled Trial Jae Hoon Chung, Dong Hyuk Kang, Cheol Young Oh, Jae Min Chung, Ki Soo Lee, Tae Hyo Kim, Kyung Hyun Moon, Wan Lee, Jeong Man Cho, and Seung Wook Lee Jae Hoon ChungJae Hoon Chung Department of Urology, Hanyang University College of Medicine, Seoul, Korea , Dong Hyuk KangDong Hyuk Kang Department of Urology, Hanyang University College of Medicine, Seoul, Korea , Cheol Young OhCheol Young Oh Department of Urology, College of Medicine, Hallym University, Chuncheon, Busan, Korea , Jae Min ChungJae Min Chung Department of Urology, Kosin University College of Medicine, Busan, Korea , Ki Soo LeeKi Soo Lee Dong-A University College of Medicine, Busan, Korea , Tae Hyo KimTae Hyo Kim Dong-A University College of Medicine, Busan, Korea , Kyung Hyun MoonKyung Hyun Moon Department of Urology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea , Wan LeeWan Lee Department of Urology, Cancer Center, Dongnam Institute of Radiological & Medical Science, Busan, Korea , Jeong Man ChoJeong Man Cho Department of Urology, Eulji University School of Medicine, Gyeonggi-do, Korea , and Seung Wook LeeSeung Wook Lee Department of Urology, Hanyang University College of Medicine, Seoul, Korea View All Author Informationhttps://doi.org/10.1016/j.juro.2012.08.243AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: We evaluated the improvement in erectile dysfunction and lower urinary tract symptoms as well as the safety of once daily administration of 50 mg mirodenafil in men with erectile dysfunction. Materials and Methods: A total of 226 patients visited for treatment of erectile dysfunction and were recruited for the study. Of these men 180 met the study inclusion criteria after completing a 2-week screening period (visit [V]1). The patients were randomly allocated into 2 groups. Group 1 (90 patients) received 50 mg mirodenafil once daily and group 2 (90 patients) received a placebo daily. Blood pressure, heart rate, IIEF-5 (5-item version of the International Index of Erectile Function), and SEP (Sexual Encounter Profile) questions 2 and 3 were assessed at 4 (V2), 8 (V3) and 12 weeks after the start of treatment (V4). I-PSS (International Prostate Symptom Score), maximal flow rate and post-void residual volume were also assessed for the evaluation of lower urinary tract symptoms. Results: Of the 180 patients 71 in group 1 and 63 in group 2 completed the 12-week clinical trial. IIEF-5 and I-PSS significantly improved in group 1 (p <0.001 for both). 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Volume 189Issue 3March 2013Page: 1006-1013Supplementary Materials Advertisement Copyright & Permissions© 2013 by American Urological Association Education and Research, Inc.Keywordserectile dysfunctionsafetyphosphodiesterase 5 inhibitorsMetricsAuthor Information Jae Hoon Chung Department of Urology, Hanyang University College of Medicine, Seoul, Korea More articles by this author Dong Hyuk Kang Department of Urology, Hanyang University College of Medicine, Seoul, Korea More articles by this author Cheol Young Oh Department of Urology, College of Medicine, Hallym University, Chuncheon, Busan, Korea More articles by this author Jae Min Chung Department of Urology, Kosin University College of Medicine, Busan, Korea More articles by this author Ki Soo Lee Dong-A University College of Medicine, Busan, Korea More articles by this author Tae Hyo Kim Dong-A University College of Medicine, Busan, Korea More articles by this author Kyung Hyun Moon Department of Urology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea More articles by this author Wan Lee Department of Urology, Cancer Center, Dongnam Institute of Radiological & Medical Science, Busan, Korea More articles by this author Jeong Man Cho Department of Urology, Eulji University School of Medicine, Gyeonggi-do, Korea More articles by this author Seung Wook Lee Department of Urology, Hanyang University College of Medicine, Seoul, Korea More articles by this author Expand All Advertisement PDF downloadLoading ...