New Study Showed LEVITRA(R) (vardenafil HCl) Improved Erectile Function While Reducing Depressive Symptoms in Men Treated for Erectile Dysfunction (ED) WEST HAVEN, Conn., and PHILADELPHIA, March 24 /PRNewswire-FirstCall/ -- A new study being presented today at the 19th Congress of the European Association of Urology (EAU) in Vienna may give hope to men with erectile dysfunction (ED) who also have depressive symptoms. The first clinical study to evaluate LEVITRA(R) (vardenafil HCl) in men with both ED and untreated mild to moderate major depressive disorder (MDD), showed that Levitra significantly improved all measures of erectile function (EF) that were studied compared with placebo.(1) Men with ED taking Levitra were nearly three times more likely to report improved erections than men taking placebo.(1) In addition, some improvements in depression and self-esteem were seen with Levitra compared with placebo. Results from the study, referred to as the DRIVER (Depression Related Improvement with Vardenafil for Erectile Response) trial, are being presented for the first time at EAU. Research has shown that ED and depression are strongly associated.(2) ED can be a consequence of depression, or ED may result in depression.(3) According to a study of men's attitudes towards life events and sexuality, 25 percent of men with ED reported symptoms of depression or anxiety.(4) "We know that many men with ED also suffer from depression, and it is likely that ED can be a causative factor for depression," said Raymond Rosen, M.D., study investigator and professor of Psychiatry and director of the Human Sexuality Program at the University of Medicine and Dentistry of New Jersey (UMDNJ) - Robert Wood Johnson Medical School in New Brunswick, N.J. "These findings reinforce the importance of rapid and reliable diagnosis and treatment of ED if the wider well-being of men is to be supported." The multicenter, double-blind, flexible-dose trial studied men with ED and untreated mild to moderate MDD.* A total of 280 men with a history of ED for longer than six months were randomized to receive Levitra 10 mg or placebo for four weeks. At weeks four and eight, physicians could adjust the dose of Levitra based on the efficacy and tolerability of thedrug. Patients either remained on their previous dose of Levitra or placebo, or the dose was increased or decreased by one step according to the three applicable dosage strengths (5 mg, 10 mg or 20mg). The total duration of treatment was 12 weeks. All efficacy measures related to ED significantly improved with Levitra compared with placebo.(1) After 12 weeks, results showed that: -- EF domain scores (a measure of ED severity) improved from moderate to mild (13.2 to 22.9) among men taking Levitra but remained at moderate (13.6 to 14.9) among men taking placebo (p