Vardenafil Helps Men Achieve Orgasmic Sexual Intercourse, Study Shows
Significant Improvements in Erectile Function, Intercourse Satisfaction, and Orgasmic Function

New York /PSA Rising/ June 1, 2001 -- An international Phase II study of nearly 500 men shows vardenafil significantly improved their ability to consistently complete sexual intercourse. This improvement was achieved early and maintained over the three-month study period, according to data to be presented next week during the 96th Annual Meeting of the American Urological Association (AUA). Vardenafil is Bayer's investigational treatment to improve erectile function.

"Vardenafil consistently improved several different aspects of sexual function, including erectile and orgasmic function, and intercourse satisfaction," said Jay M. Young, M.D., medical director of South Orange County Medical Research Center and lead author of the analysis. "This is important because my patients tell me that in order to enjoy a satisfactory and healthy sex life, they need to feel confident their erections will last long enough to complete sexual intercourse, and they need to know this will happen consistently."

In fact, in a recent survey of 100 men with impaired erectile function, 83 percent said they would be interested in a new treatment for impaired erectile function if it allowed them to achieve an erection and successfully complete intercourse. The survey also found that 76 percent of patients would be interested in a new treatment that works reliably.

In another survey of 100 physicians, including urologists and family physicians, 93 percent agreed that new treatments are needed to improve erectile function. In addition, 96 percent said they would be willing to prescribe a new therapy that provided dose-to-dose reliability.

The surveys explored the opinions of patients with impaired erectile function and the perceptions of physicians who treat the condition. The survey was sponsored by Bayer Corporation and designed by Fleishman-Hillard Research. The patient interviews were conducted by NFO WorldGroup, and physician interviews were conducted by Schlesinger Associates and Communications for Research.

Referring to the Phase II vardenafil study to be presented at the AUA, Young added, "A treatment that works consistently over time also will help to enhance satisfaction for men and their partners."

Study Design and Findings

The study involved 489 men, ages 21-70 years, with mild to severe impaired erectile function. It took place at 39 treatment centers in seven countries (United States, Belgium, France, Germany, the Netherlands, Poland, and South Africa). The patients were randomized into four groups and were given an oral tablet form of 5 mg, 10 mg, or 20 mg doses of vardenafil (a phosphodiesterase 5 [PDEýÓ5] inhibitor), or placebo on demand.

The participants were then asked to record their responses in a patient diary, noting the number of times they completed sexual intercourse. Before treatment, approximately 25 percent of attempts at intercourse were completed successfully. But after twelve weeks of treatment with vardenafil, more than three times that number of attempts (approximately 75 percent) were completed successfully.

In addition to the diary, study participants were evaluated using the erectile function domain of the International Index of Erectile Function (IIEF), a standard sexual function questionnaire used by urologists. The men answered the questionnaire at intervals of four, eight, and 12 weeks. Each answer is assigned a points value, with a maximum of 30 points possible. Anyone scoring between 26 and 30 points is considered to have normal sexual function. In this study, the mean score before treatment was approximately 14.

Over the first four weeks, mean scores for the 5 mg, 10 mg, and 20 mg groups increased to 20.3, 21.5, and 23.2, respectively. In contrast, mean scores for the placebo group increased to 15.9. The vardenafil groups were more successful in achieving erections than patients receiving placebo throughout the 12-week study period.

The occurrence of adverse events was generally low throughout the study period and included headaches, flushing (reddening of the face), and stomach upset. No drug related serious adverse events occurred.

Positive Trial Results A separate analysis of Phase II data presented at the European Association of Urology annual meeting showed vardenafil improved erectile function in men regardless of age, cause, or the severity of erectile impairment. In addition, the study showed vardenafil improved erections in up to 80 percent of men. Phase III data on vardenafil will be presented at the American Diabetes Association Meeting later this month.

Vardenafil is an oral treatment currently under investigation to improve erectile function. Bayer plans to submit a new drug application (NDA) for this compound to the U.S. Food and Drug Administration later this year.