Efficacy and Tolerability of Flexible-Dose Vardenafil When Taken 8 hours Before Intercourse: The Extended Duration of Vardenafil in Erectile Dysfunction (EXTEND) Trial.Efficacy and Tolerability of Flexible-Dose Vardenafil When Taken 8 hours Before Intercourse: The Extended Duration of Vardenafil in Erectile Dysfunction Erectile Dysfunction Definition Erectile dysfunction (ED), formerly known as impotence, is the inability to achieve or maintain an erection long enough to engage in sexual intercourse. (EXTEND) Trial, Hartmut Porst, Practice of Urology urology Medical specialty dealing with the urinary system and male reproductive organs. It traces its origin to medieval lithologists, itinerant healers who specialized in surgical removal of bladder stones. and Andrology; Ira Sharlip, Pan-Pacific Urology; Dimitrios Hatzichristou, 2nd Department of Urology and Center for Sexual and Reproductive Health Within the framework of WHO's definition of health[1] as a state of complete physical, mental and social well-being, and not merely the absence of disease or infirmity, reproductive health, or sexual health/hygiene ; Eusebio Rubio-Aurioles, Asociacion Mexicana Para la Salud Sexual; Marc Gittleman, South Florida Medical Research; Britt-Nicole Stancil and H. Jeffrey Wilkins, GlaxoSmithKline; Peter Pommerville, Can-Med Clinical Research Inc. We evaluated the efficacy of vardenafil in men with erectile dysfunction (ED) when taken 8 hours prior to sexual intercourse sexual intercourse or coitus or copulation Act in which the male reproductive organ enters the female reproductive tract (see reproductive system). . Men with ED for more than 6 months and who failed at least 50% of intercourse attempts during a 4-week treatment-free run-in period were randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. to flexible-dose vardenafil or placebo for 10 weeks. Patients were instructed to take the study drug 8 hours before attempting sexual intercourse. The starting dose of vardenafil was 10 mg with the option to titrate ti·trate v. To determine the concentration of a solution by titration or perform the operation of titration. ti to 5 mg or 20 mg at Weeks 2 and 6. Efficacy measures included Sexual Encounter Profile questions 2 (penetration) and 3 (maintenance of erection), Erectile Function (EF) domain score of the International Index of Erectile Function, and the Global Assessment Question (GAQ GAQ Global Assessment Questionnaire ). Data from Weeks 2 to 10 for doses taken 8 [+ or -] 2 hours before sexual intercourse were used in the analysis. A total of 383 patients were randomized to vardenafil (n = 194) or placebo (n = 189). Most had severe (36%) or moderate (31%) ED at baseline; mean EF domain score was 13. Over Weeks 2-10, least square (LS) mean per-patient success rates were significantly greater with vardenafil compared with placebo for penetration and maintenance of erection. At Week 10, LS mean EF domain score was significantly higher in the vardenafil group compared with placebo. Significantly more patients reported improved erections according to positive responses to GAQ with vardenafil compared with placebo. Vardenafil was generally well-tolerated. These results demonstrate that patients can successfully use vardenafil when intercourse is attempted up to 8 hours after dosing. |
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