2002-05-28 10:00:21 -0400
By Emma Hitt, PhD
ORLANDO, Florida (Reuters Health) - Men with erectile dysfunction can have sexual intercourse for up to 36 hours after taking a single dose of an experimental drug called tadalafil (Cialis), according to new study findings released here Sunday.
Tadalafil provides an advantage to couples by making sex more spontaneous, "because a person doesn't have to take the pill just before having sex," commented Dr. Hartmut Porst of the University of Hamburg, Germany, who presented the findings at the American Urological Association's annual meeting.
Porst and colleagues enrolled 348 men with mild to severe erectile dysfunction in 36 centers in Europe and the United States. Patients received either 20 milligrams of tadalafil or an inactive placebo over about 8 weeks.
During the study, patients were asked to attempt intercourse with their partners on four occasions: twice 24 hours after taking the pill and twice 36 hours after taking it.
About 60% of patients taking tadalafil were able to maintain an erection sufficient for sexual intercourse at 24 hours and 36 hours after taking the pill, compared with about 30% of patients taking the placebo.
The researchers also evaluated penetration ability, hardness of erection and overall satisfaction, and found that tadalafil was more effective than placebo at 24 and 36 hours after dosing.
"Some of my patients tell me that they are still able to perform sexual intercourse 3 days after taking one pill," Porst noted during a press conference.
According to Porst, patients can take tadalafil every day because the drug does not reach toxic levels in the body.
Indigestion, flushing, and headache were the most common side effects, but these were generally mild and decreased as the patients continued to use the drug, Porst said.
The study was funded by the manufacturers of the drug, Lilly ICOS. In
April, the US Food and Drug Administration issued an approvable letter
to Lilly ICOS for tadalafil, which means the regulator may approve the
drug pending the results of additional studies. Lilly ICOS said it expects
to launch the drug in the US in 2003.
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