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Dapoxetine effective for premature ejaculation disorder
According to the results of a phase 2 multicenter, double-blind, randomized, placebo-controlled,
3-phase crossover trial presented at the 11th World Congress of the International Society for
Sexual and Impotence Research in Buenos Aires, Argentina
Dapoxetine is well tolerated and is effective in improving premature ejaculation.
To evaluate the tolerability and efficacy of dapoxetine compared with placebo, Dr. Hellstrom and
his team randomized 166 male patients aged 23 to 64 years with a baseline intravaginal ejaculatory
latency time (IELT) of fewer than two minutes (mean, 1.01 minutes) to a series of three crossover
treatment periods with dapoxetine 60 mg, dapoxetine 100 mg, and placebo, each separated by 72-hour
washout periods. All subjects were involved in a monogamous relationship lasting at least six months;
130 subjects completed the study.
Results of an intent-to-treat analysis showed that dapoxetine 60 mg and 100 mg is effective. It significantly increased
IELT compared with placebo (2.94 minutes for the 60-mg group and 3.20 minutes for the 100-mg group compared
with 2.05 minutes for the placebo group; P < .0001 for both).
"On the basis of these results — the increase in intravaginal ejaculation time to about three minutes
from one minute, and the fact that the 60-mg dose didn't have any adverse effects — Johnson & Johnson
decided to use the 60-mg dose in large-scale clinical trials [that are] currently in progress,"
Dr. Hellstrom said, noting that dapoxetine will likely be available for clinical use in the next
six to 12 months.
Before treatment, only about 3 percent of the men reported at least fair control over ejaculation.
After placebo treatment, a surprising 26.4 percent of men reported fair control. Even so, more men reported
fair-or-better control after taking dapoxetine: 51.8 percent in the low-dose group, and 58.4 percent
in the high-dose group.
Dapoxetine data demonstrates that men taking dapoxetine hydrochloride for the treatment of premature ejaculation disorder
experienced significant improvements in sexual function, including ejaculatory control, satisfaction with sexual
intercourse for men and their partners, and increases in intravaginal ejaculatory latency time (IELT)*.
These data were presented at the 100th Annual Scientific Meeting of the American Urological Association.
NOTE:
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and is not meant to substitute for the advice of your own physician or other medical professional.
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