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• W2031030811 abstract "You have accessJournal of UrologySexual Function/Dysfunction/Andrology: Medical and Non-surgical1 Apr 2014MP48-11 TIME TO ERECTOGENIC EFFECT OF AVANAFIL IN A RANDOMIZED, PLACEBO-CONTROLLED TRIAL Wayne J.G. Hellstrom, David Cook, LeRoy Jones, Charles H. Bowden, Wesley W. Day, and Chien-Feng Chen Wayne J.G. HellstromWayne J.G. Hellstrom More articles by this author , David CookDavid Cook More articles by this author , LeRoy JonesLeRoy Jones More articles by this author , Charles H. BowdenCharles H. Bowden More articles by this author , Wesley W. DayWesley W. Day More articles by this author , and Chien-Feng ChenChien-Feng Chen More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2014.02.1485AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail Introduction and Objectives Avanafil is a highly specific phosphodiesterase type 5 inhibitor approved for the treatment of erectile dysfunction (ED). This phase 4 study examined the efficacy and safety of avanafil approximately 15 minutes after dosing in men with mild to severe ED. Methods In this double-blind, 12-week (4-week run-in; 8-week treatment period) study, patients were randomized to placebo (n=145), avanafil 100 mg (n=147), or avanafil 200 mg (n=148). Sexual function was assessed at baseline and at all follow-up visits using patient diaries and the International Index of Erectile Function (IIEF). The primary objective was to assess positive responses to Sexual Encounter Profile question 3 (SEP3) within approximately 15 minutes post-dosing. Patients were encouraged to attempt intercourse approximately 15 minutes post-dosing; stopwatches were used to measure timing of response. Other endpoints included the percentage of sexual attempts in which patients were able to insert the penis into the partner’s vagina (SEP2), percentage of successful sexual attempts in which patients maintained an erection of sufficient duration to have successful intercourse (SEP3), and change in the erectile function (EF) domain of IIEF. Results At baseline, mean age was 58±10 years; 41% of patients had severe ED; mean duration of ED was 89±70 months, and 60% had a history of sildenafil use. After 8 weeks of treatment, significant improvements were observed in all endpoints, including successful intercourse attempts (SEP3) within approximately 15 minutes after dosing with both avanafil doses (P<.01 vs placebo; Table) and as early as 10 minutes post-dosing in the avanafil 200-mg group and 12 minutes post-dosing in the avanafil 100-mg group (P<.01 vs placebo). Common adverse events were headache, nasopharyngitis, and flushing. Conclusions Avanafil had a significant erectogenic effect compared with placebo, including successful achievement of SEP2, SEP3, and changes in the IIEF-EF domain score. Furthermore, a significant number of sexual attempts were successful within approximately 15 minutes post-dosing. Table. Erectogenic Effects of Avanafil in Men With Mild to Severe ED During 8 Weeks of Treatment (ITT). Placebo Avanfil 100 mg Avanafil 200 mg Successful Vaginal Penetration, SEP2 n 136 138 139 LS Mean Percentage of Sexual Attempts (SE) 43.5 (3.2) 65.0 (3.2)∗ 65.4 (3.2)∗ Successful Intercourse, SEP3 n 136 138 139 LS Mean Percentage of Sexual Attempts (SE) 27.7 (3.3) 47.0 (3.3)∗ 48.7 (3.3)∗ Successful Intercourse (SEP3) Within Approximately 15 Minutes Post-dosing‡ n 136 138 139 LS Mean Percentage of Sexual Attempts (SE) 13.8 (2.9) 24.7 (2.9)† 28.2 (2.9)∗ IIEF-EF Domain Score n 135 138 139 LS Mean (SE) 13.9 (0.8) 18.1 (0.8)∗ 19.1 (0.8)∗ ∗ P< .001 vs placebo; †P=.002 vs placebo; ‡Any erectogenic effect that had a stopwatch time of ≤17 minutes to include up to 17 minutes and 59 seconds could be considered to be within approximately 15 minutes. ITT, intent-to-treat population; LS, least squares; SE, standard error © 2014FiguresReferencesRelatedDetails Volume 191Issue 4SApril 2014Page: e531 Advertisement Copyright & Permissions© 2014MetricsAuthor Information Wayne J.G. Hellstrom More articles by this author David Cook More articles by this author LeRoy Jones More articles by this author Charles H. Bowden More articles by this author Wesley W. Day More articles by this author Chien-Feng Chen More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ..." @default.
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• W2031030811 title "MP48-11 TIME TO ERECTOGENIC EFFECT OF AVANAFIL IN A RANDOMIZED, PLACEBO-CONTROLLED TRIAL" @default.
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