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Vardenafil Improves Even Severe Erectile Dysfunction PDF Print E-mail
ORLANDO - May 25, 2002 -Vardenafil significantly improved erectile function (EF) in men suffering from erectile dysfunction (ED), regardless of the origin or baseline severity of their condition, according to a new study conducted by Craig Donatucci, M.D., urologist in practice at the Duke University Medical Center in Durham, NC. His findings will be presented at the American Urological Association Annual Scientific Meeting on May 27 at 2:20 p.m. during a podium session.

The 12-week phase IIb trial consisted of two randomized, double-blind trials of 1,357men, ages 18 or older, suffering from ED for longer than six months to analyze efficacy and safety of the drug. The primary efficacy variable, using the International Index of Erectile Function (EF Domain) was analyzed within subgroups defined by etiology - the origin of ED - and baseline severity defined from EF domain score.

 

Regardless of dose, vardenafil significantly improved ED, irrespective of etiology or severity.

 

The phase III trial of vardenafil will be a pivotal study to prove its the efficacy and safety. Adverse effects were dose-related (five, 10 or 20 milligram, or placebo) and were mostly mild to moderate in intensity, including headache, vasodilation, rhinitis, dyspepsia and acid reflux.

 

"Erectile dysfunction arises from multiple etiologies and manifests from mild to severe," Donatucci said. "In the trial, vardenafil significantly improved erectile dysfunction and was well tolerated by trial participants. It could be yet another option to effectively treat this condition."


Additional resources on erectile dysfunction are available from MayoClinic.com:

http://www.mayoclinic.com/health/erectile-dysfunction/DS00162
 
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