1481 A RANDOMIZED, PLACEBO CONTROLLED, DOUBLE BLIND, MULTICENTER THERAPEUTIC EXPLORATORY CLINICAL STUDY FOR THE EVALUATION OF THE EFFICACY AND SAFETY OF AVANAFIL IN THE PATIENTS WITH ERECTILE DYSFUNCTION

Abstract

You have accessJournal of UrologySexual Function/Dysfunction/Andrology: Medical and Non-Surgical Therapy1 Apr 20121481 A RANDOMIZED, PLACEBO CONTROLLED, DOUBLE BLIND, MULTICENTER THERAPEUTIC EXPLORATORY CLINICAL STUDY FOR THE EVALUATION OF THE EFFICACY AND SAFETY OF AVANAFIL IN THE PATIENTS WITH ERECTILE DYSFUNCTION Hyun Jun Park, Nam Cheol Park, Se Woong Kim, Je Jong Kim, Sung Won Lee, Jae Weung Paick, Tae Young Ahn, Kwangsung Park, and Jong Kwan Park Hyun Jun ParkHyun Jun Park Busan, Korea, Republic of More articles by this author , Nam Cheol ParkNam Cheol Park Busan, Korea, Republic of More articles by this author , Se Woong KimSe Woong Kim Seoul, Korea, Republic of More articles by this author , Je Jong KimJe Jong Kim Seoul, Korea, Republic of More articles by this author , Sung Won LeeSung Won Lee Seoul, Korea, Republic of More articles by this author , Jae Weung PaickJae Weung Paick Seoul, Korea, Republic of More articles by this author , Tae Young AhnTae Young Ahn Seoul, Korea, Republic of More articles by this author , Kwangsung ParkKwangsung Park Gwangju, Korea, Republic of More articles by this author , and Jong Kwan ParkJong Kwan Park Jeonju, Korea, Republic of More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2012.02.2003AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Avanafil is a newly developed selective PDE5 inhibitor for the treatment of ED. The aim of this exploratory clinical study is to evaluate the efficacy and safety of avanafil in the treatment of ED in Korean men. METHODS 158 patients with ED were participated in a placebo controlled, double blind, multicenter trial and randomized to receive placebo, 50mg, 100mg or 200mg of avanafil for 8 weeks. The primary efficacy variable was the change of IIEF-EF domain score. The secondary efficacy measures included the response to SEP Q2-3, the change of score in IIEF Q3-4, GEAQ and normal erectile function rate (IIEF EF domain score¡Ã26). RESULTS The change in EF domain scores of each dosage was statistically significant. In multiple comparisons, all dosage groups except for avanafil 50mg showed significant difference compared to placebo. In SEP Q2 and Q3, the change in success rate of each dosage group was statistically significant. However, avanafil 50mg did not show a significant difference compared to placebo. The change in score of IIEF Q3and Q4 of each dosage group was statistically significant. In multiple comparisons, all dosage groups of avanafil showed significant difference compared to placebo in IIEF Q3. However, only avanafil 200mg showed significant difference compared to placebo in IIEF Q4. All dosage groups except for avanafil 50mg showed significant difference compared to placebo in GEAQ. Ratio of normal erectile function of each dosage was significant, and avanafil 200mg showed significant difference compared to placebo. Most treatment-emergent adverse event was of mild intensity, recovering spontaneously. CONCLUSIONS Avanafil at 100mg and 200mg was an effective and well tolerated in the treatment for the ED in Korea men. © 2012 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 187Issue 4SApril 2012Page: e600 Advertisement Copyright & Permissions© 2012 by American Urological Association Education and Research, Inc.MetricsAuthor Information Hyun Jun Park Busan, Korea, Republic of More articles by this author Nam Cheol Park Busan, Korea, Republic of More articles by this author Se Woong Kim Seoul, Korea, Republic of More articles by this author Je Jong Kim Seoul, Korea, Republic of More articles by this author Sung Won Lee Seoul, Korea, Republic of More articles by this author Jae Weung Paick Seoul, Korea, Republic of More articles by this author Tae Young Ahn Seoul, Korea, Republic of More articles by this author Kwangsung Park Gwangju, Korea, Republic of More articles by this author Jong Kwan Park Jeonju, Korea, Republic of More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...