The first clinical study to evaluate Levitra (vardenafil HCl) in men with mild Major Depressive Disorder (MDD) and erectile dysfunction (ED) showed Levitra produced statistically significant improvements over baseline in all measures of erectile function (EF) and depression/self-esteem. In the study, men taking Levitra were nearly three times more likely to report improved erections than men taking placebo.

Results from the study, referred to as the DRIVER (Depression Related Improvement with Vardenafil for Erectile Response) trial, will be presented for the first time at the 19th Congress of the European Association of Urology (EAU) in Vienna.

Previous research has shown a link between depression and ED. According to the largest ever study of men's attitudes to life events and sexuality, 25 per cent of men with ED reported depression and anxiety; and 26 per cent of men with depression and anxiety reported ED.

"We know that many men with ED also suffer from depression, and it is likely that ED can be a causative factor for depression. It's therefore encouraging to find that Levitra is so effective in improving a man's erectile function that it can help alleviate his depression and improve his self-esteem," said Prof Raymond Rosen, study investigator and Professor of Psychiatry and Director of the Human Sexuality Program at the UMDNJ-Robert Wood Johnson Medical School in New Brunswick, New Jersey.

"These findings reinforce the importance of rapid and reliable diagnosis and treatment of ED so men don't continue to suffer from a condition that negatively impacts on their quality of life," Dr Rosen concluded.

This multicentre, double-blind, flexible-dose trial studied men with ED and mild MDD (as assessed by DSM IV and HAM-D17). A total of 280 adult men with more than six months history of ED were randomised to receive Levitra 10mg or placebo for four weeks.

At weeks four and eight of the trial, physicians could adjust the dose of Levitra from the starting dose of 10mg to 20mg or 5mg based on the efficacy and tolerability of the drug. The total duration of treatment was 12 weeks.

All primary endpoints showed statistically significant improvements compared with placebo. Results showed that after 12 weeks, the magnitude of improvement in the HAM-D17 score was greater in the Levitra-treated group relative to placebo (p=0.0001). In addition, men taking Levitra were nearly three times more likely to report improved erections than men taking placebo (83 per cent vs. 30 per cent GAQ, respectively, p<0.0001).

In the clinical trial, the most commonly reported adverse events were generally mild to moderate, these included nasal congestion, headache and flushing.

Additional study demonstrates that Levitra shows reliable efficacy over time and a rapid onset of action even in men who had not responded to treatment with Viagra, on history.