Erectile Dysfunction Clinical Trial
Official title:
Multi-Centre, Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction Caused by Spinal Cord Injury
The purpose of this study is to determine if 12 weeks of flexible-dose vardenafil therapy demonstrates superior efficacy compared to placebo in subjects with ED solely secondary to a traumatic spinal cord injury
According to the Massachusetts Male Aging Study, erectile dysfunction (ED) is estimated as
affecting approximately 30 million American men and 100 million men worldwide. The study
also reported that approximately 52% of males aged 40-70 experience some degree of ED.
Prevalence has been shown to increase with age, with an estimated 40% of the responders
experiencing ED at age 40, whereas, 67% had difficulties by age 75.
Considerable advances have been made since the NIH Consensus statement that defined ED as
the persistent inability to achieve and maintain an erection sufficient for satisfactory
sexual performance. However, one thing remains the same, sexuality continues to be a driving
force in our society today. Many men with erectile dysfunction suffer from issues of self
esteem, self worth, the creation and maintenance of interpersonal relationships and in
general, wrestle with an overall altered sense of wellbeing. Damage to personal
relationships can ensue; and the anger, depression, and anxiety engendered spill over into
all aspects of life.
VIAGRA(sildenafil), administered as a flexible-dose regimen, has demonstrated to be an
effective and well-tolerated treatment for ED in spinal cord injury sufferers.This is a
multi-centre, prospective, randomized, double-blind, placebo-controlled study to evaluate
the efficacy and safety of vardenafil in men with erectile dysfunction caused by spinal cord
injury.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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