Complete Title: Effect of levitra on sustenance of erection (EROS): An open-label, prospective, multicenter, single-arm study to investigate erection duration measured by stopwatch with flexible dose vardenafil administered for 8 weeks in subjects with erectile dysfunction
Context 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.
Written by:
Shin YS, Lee SW, Park K, Chung WS, Kim SW, Hyun JS, Moon DG, Yang SK, Ryu JK, Yang DY, Moon KH, Min KS, Park JK. Are you the author?
Department of Urology, Chonbuk National University Medical School and Institute for Medical Sciences, Chonbuk National University and Biomedical Research Institute and Clinical Trial Center of Medical Device of Chonbuk National University Hospital, Jeonju, South Korea; Department of Urology, Sungkyunkwan University School of Medicine, Seoul, Korea; Department of Urology, Chonnam National University Medical School, Gwangju, Korea; Department of Urology, Ewha Womans University School of Medicine, Seoul, Korea; Department of Urology, The Catholic University of Korea College of Medicine, Seoul, Korea; Department of Urology, Gyeongsang National University School of Medicine, Jinju, Korea; Department of Urology, Korea University College of Medicine, Seoul, Korea; Department of Urology, Konkuk University School of Medicine, Chungju, Korea; Department of Urology, Inha University School of Medicine, Incheon, Korea; Department of Urology, Hallym University College of Medicine, Chuncheon, Korea; Department of Urology, Yeungnam University College of Medicine, Daegu, Korea; Department of Urology, Inje University Busan Paik Hospital, Inje University College of Medicine, Busan, Korea.
Reference: Int J Impot Res. 2014 Dec 4. Epub ahead of print.
doi: 10.1038/ijir.2014.39
PubMed Abstract
PMID: 25471318