STUDY SHOWS NEW INVESTIGATIONAL DRUG TADALAFIL SUCCESFULLY TREATED ERECTILE DYSFUNCTION UP TO 36 HOURS AFTER DOSING
ORLANDO - May 25, 2002 - A study of the investigational drug tadalafil, a new oral PDE5 inhibitor, found that it increased intercourse success in men with erectile dysfunction (ED) at up to 36 hours after dosing. The study was conducted by Dr. Hartmut Porstclinical investigator in private urological practice in Hamburg, Germany and the international tadalafil study group. He will present the findings at the American Urological Association annual meeting on May x.
In the study, 348 men with mild to severe ED were given either tadalafil 20-mg or placebo. Patients were asked to attempt intercourse on four separate occasions: once 24 hours after a dose, once again 24 hours after a dose, once 36 hours after a dose, and once again 36 hours after a dose.
Tadalafil significantly increased the percentage of successful intercourse attempts at 24 hours (57 percent) and 36 hours (60 percent) post dose compared with placebo (31 percent and 30 percent, respectively). Secondary measures of efficacy -- penetration ability, hardness of erection, overall satisfaction - showed tadalafil to have greater efficacy than placebo at both 24 hours and 36 hours post dose.
Tadalafil was well tolerated; headache, flushing and dyspepsia (upset stomach) were the most common side effects, but most were mild to moderate in intensity. The extended duration of effectiveness did not appear to increase the rate of side effects or their severity, and very few patients receiving placebo or tadalafil discontinued due to side effects.
"We are very pleased to see that tadalafil allowed a majority of men in this trial to achieve normal sexual functioning at up to 36 hours after taking the drug," said Dr. Porst. "The extended duration of responsiveness may help eliminate the need for planning sexual intimacy and could potentially set new expectations in the treatment of ED."
Erectile dysfunction is the consistent inability to attain or sustain an erection adequate for satisfactory sexual intercourse. It is estimated to affect more than 30 million men in the United States.
Additional resources on erectile dysfunction are available from MayoClinic.com:
http://www.mayoclinic.com/health/erectile-dysfunction/DS00162
