Effect of Levitra on Sustenance of Erection (EROS)
Effect of Levitra on Sustenance of Erection (EROS)
To investigate the change of erection duration measured by stopwatch with flexible dose vardenafil administered for 8 weeks in subjects with erectile dysfunction (ED). Effect of levitra on sustenance of erection was an open-label, prospective, multicenter and single-arm study designed to measure the duration of erection in men with ED receiving a flexible dose of vardenafil over an 8-week treatment period. Patients were instructed to take vardenafil 10 mg 60 min before attempting the intercourse. Vardenfil could be increased to 20 mg or decreased to 5 mg concerning patients' efficacy and safety. Following the initial screening, patients entered a 4-week treatment-free run-in phase and 8-week treatment period, during which they were instructed to attempt intercourse at least four times on four separate days. A total of 95 men were enrolled in 10 centers. After the 8 weeks treatment, the mean duration of erection leading to successful intercourse was statistically superior when patients were treated with vardenafil. After an 8-week treatment, the duration of erection leading to successful intercourse was 9.39 min. There were significant benefits with vardenafil in all domains of International Index of Erectile Function. Secondary efficacy end points included success rate of penetration, maintaining erection, ejaculation and satisfaction were superior when patients were treated with vardenafil. There was a significant correlation between duration of erection with other sexual factors. Also partner's sexual satisfaction was increased with vardenafil. Most adverse events were mild or moderate in severity. Vardenafil was safe and well tolerated. Vardenafil therapy provided a statistically superior duration of erection leading to successful intercourse in men with ED with female partner.
Erectile dysfunction (ED), defined as a persistent and consistent inability to achieve penile erection during sexual intercourse, is one of the most common sexual disorders among men. Nearly 50% of men reported some degree of ED and and about 65% are not satisfied with the hardness of their erection. Moreover, the female partners of men with ED also have reduced sexual desire, arousal and satisfaction.
Oral phosphodiesterase type 5 (PDE5) inhibitors are recommended as first-line therapy for the treatment of ED. Vardenafil, a potent and selective PDE5 inhibitor, has been shown in clinical trials to be reliably effective in men with ED. Given this background, we investigated the change of erection duration measured by stopwatch with flexible dose of vardenafil administered for 8 weeks in subjects with ED of broad-spectrum etiology and severity, and satisfaction to treatment among both patients receiving vardenafil and their partners.
To our knowledge, effect of levitra on sustenance of erection (EROS) is the first clinical trial targeting Asians using a stopwatch assessment tool to measure duration of erection leading to successful intercourse as a primary efficacy end point following PDE5 inhibitor therapy.
Abstract and Introduction
Abstract
To investigate the change of erection duration measured by stopwatch with flexible dose vardenafil administered for 8 weeks in subjects with erectile dysfunction (ED). Effect of levitra on sustenance of erection was an open-label, prospective, multicenter and single-arm study designed to measure the duration of erection in men with ED receiving a flexible dose of vardenafil over an 8-week treatment period. Patients were instructed to take vardenafil 10 mg 60 min before attempting the intercourse. Vardenfil could be increased to 20 mg or decreased to 5 mg concerning patients' efficacy and safety. Following the initial screening, patients entered a 4-week treatment-free run-in phase and 8-week treatment period, during which they were instructed to attempt intercourse at least four times on four separate days. A total of 95 men were enrolled in 10 centers. After the 8 weeks treatment, the mean duration of erection leading to successful intercourse was statistically superior when patients were treated with vardenafil. After an 8-week treatment, the duration of erection leading to successful intercourse was 9.39 min. There were significant benefits with vardenafil in all domains of International Index of Erectile Function. Secondary efficacy end points included success rate of penetration, maintaining erection, ejaculation and satisfaction were superior when patients were treated with vardenafil. There was a significant correlation between duration of erection with other sexual factors. Also partner's sexual satisfaction was increased with vardenafil. Most adverse events were mild or moderate in severity. Vardenafil was safe and well tolerated. Vardenafil therapy provided a statistically superior duration of erection leading to successful intercourse in men with ED with female partner.
Introduction
Erectile dysfunction (ED), defined as a persistent and consistent inability to achieve penile erection during sexual intercourse, is one of the most common sexual disorders among men. Nearly 50% of men reported some degree of ED and and about 65% are not satisfied with the hardness of their erection. Moreover, the female partners of men with ED also have reduced sexual desire, arousal and satisfaction.
Oral phosphodiesterase type 5 (PDE5) inhibitors are recommended as first-line therapy for the treatment of ED. Vardenafil, a potent and selective PDE5 inhibitor, has been shown in clinical trials to be reliably effective in men with ED. Given this background, we investigated the change of erection duration measured by stopwatch with flexible dose of vardenafil administered for 8 weeks in subjects with ED of broad-spectrum etiology and severity, and satisfaction to treatment among both patients receiving vardenafil and their partners.
To our knowledge, effect of levitra on sustenance of erection (EROS) is the first clinical trial targeting Asians using a stopwatch assessment tool to measure duration of erection leading to successful intercourse as a primary efficacy end point following PDE5 inhibitor therapy.
Source...