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Phase III Clinical Trial Results for Dapoxetine Hydrochloride
Following data presented in May 2005, at the 100th Annual Scientific Meeting of the American Urological Association,
men taking dapoxetine hydrochloride for the
treatment of premature ejaculation (PE)
experienced significant improvements in sexual function:
- ejaculatory control improvement,
- satisfaction with sexual intercourse for men and their partners,
- increases in intravaginal ejaculatory latency time (IELT).
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Caution: A person should not take more than one dapoxetine dosage in 24 hours, in any case. And it is
recommended that there should not be any alcohol intake while taking Priligy dosage.
Dapoxetine would be the first prescription product indicated for the
treatment of premature ejaculation (PE) it will be
approved by the U.S. Food and Drug Administration which is currently reviewing a New Drug Application for dapoxetine.
Premature ejaculation may be the most common male sexual disorder. In contrast to erectile dysfunction, which affects 10% to 12% of all men, who are usually older in age, it is estimated that PE may affect 27% to 34% of
men across all age ranges. PE can be a lifelong condition experienced from the beginning of sexual activity or can develop
after years of satisfactory sexual activity.
Jon L. Pryor, M.D., chairman and program director of the Department of Urologic Surgery at the University of Minnesota
and lead investigator of the dapoxetine phase III clinical trials says:
"The impact premature ejaculation can have on men and their partners can be devastating for a relationship and, currently,
there are no truly optimal therapies for premature ejaculation. The results with
dapoxetine are compelling. They demonstrate that, for the first
time, a medicine can be taken by men on an on-demand basis and provide significant improvement in their premature ejaculation condition.
The unique profile of dapoxetine translated into targeted
treatment of premature ejaculation compared to existing therapies. There are meaningful
improvements in this study across all primary and secondary endpoints, including a three-to-four fold increase in IELT."
Improvement of ejaculatory control during the trial
During the phase III clinical trials PE was defined as persistent or recurrent ejaculation sooner than desired either before or
shortly after penetration, lack of
ejaculation control, typically reflecting an IELT of two minutes or less, over which the
sufferer has minimal or no control.
Clinical trials studied 2,614 men with PE aged 18-77 in monogamous sexual relationships of greater than six months.
Men in the studies were randomized to receive 30 mg or 60 mg of
dapoxetine over 12 weeks in two identical, double-blind,
placebo-controlled, multicenter trials. Patients were asked to take study medication one-to-three hours before intercourse.
Participants had IELT of two minutes or less in at least 75% of intercourse episodes occurring during the two-week baseline
run-in period prior to treatment.
The results showed an improvement of ejaculatory control, suggesting
dapoxetine effective for premature ejaculation:
IELT increased significantly with the first dose
of dapoxetine, and increases in IELT were maintained over the 12-week
study period.
The percentage of men and their partners rating sexual satisfaction as "good to very good"
almost doubled with dapoxetine 30 mg (20.2% to 38.7%) and 60 mg (22.3%
to 46.5%), respectively, in comparison to placebo (21.6% to 24.6%).
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