Levitra Starts To Work In As Early As Ten Minutes In Men With Erectile Dysfunction

According to the results of a new study, some men with erectile dysfunction (ED) can now achieve an erection in as few as 10 minutes with Levitra (vardenafil HCl).1 These findings were presented at the 7th Congress of the European Federation of Sexology (EFS) this week. In a separate retrospective analysis of two studies, Levitra was shown to provide a favorable window of opportunity of up to 12 hours. 2

"I treat many men with ED, and for some, rapid onset is an important consideration in an oral ED treatment," said Marc Gittelman, M.D., founder and director of the Miami Center for Sexual Health and voluntary assistant professor at the University of Miami School of Medicine. "These new Levitra data are important because it is the first time any oral ED treatment has been shown to work in as early as 10 minutes. I think this is exciting news for men with ED who are looking for a treatment that is reliable, fast and provides a quality response."

In a U.S. nationwide omnibus survey conducted by Harris Interactive in April 2004, 41 percent of 206 respondents who experience ED, or have a partner who experiences ED, said they would want an ED treatment to start working in "15 minutes or less."3 The online survey, sponsored by Bayer Pharmaceuticals Corporation and GlaxoSmithKline, was conducted among a nationwide sample of 2,016 U.S. adults (1,013 men and 1,003 women).

"Waiting for an ED treatment to kick in can be stressful," said Levitra patient Frank Marcoulides "With Levitra, I know I have a treatment I can rely on to work fast and improve my erection quality. Levitra is the right choice for my wife and me."

About the ONTIME Study

In this double-blind, at-home study, men with ED (n=732) were randomized to receive Levitra (10mg or 20 mg) or placebo and asked to start sexual activity immediately after dosing and to assess their erections using a stopwatch for the first four attempts. Time-points from 25 to five minutes were tested comparing Levitra with placebo to determine the earliest onset of action. Results showed that:
- Within 25 minutes, significantly more men taking Levitra experienced an erection adequate for completion of successful intercourse compared with men taking placebo (50 percent of men taking Levitra 10 mg and 53 percent of men taking Levitra 20 mg vs 26 percent of men taking placebo).1a

- At all time periods >10 minutes, a statistically superior response was seen with Levitra (10 mg and 20 mg) compared with placebo (49 out of 232 for Levitra 10 mg vs 32 out of 235 for placebo 10 mg; 56 out of 241 for Levitra 20 mg vs 35 out of 235 for placebo 20 mg).1b

- The most commonly reported adverse events were generally mild to moderate and included headache and flushing.1c

Window of Opportunity Analysis

In a retrospective, pooled analysis of two pivotal, randomized, double-blind, placebo-controlled Phase III studies involving 1385 patients with ED, patients were instructed to take Levitra 60 minutes prior to sexual activity. Results showed that: