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Clinical Trials on Priligy (Dapoxetine)

Methods
A random analysis of two 12-weeks, phase III trials of similar design done independently, in parallel, at 121 sites in the USA helped to determine the effectiveness of dapoxetine. Individuals with average-severe premature ejaculation in heterosexual relationships took placebo (n=870), 30 mg dapoxetine (874), or 60 mg dapoxetine (870) on-demand (as required, 1—3 hours before any sexual activity). The main endpoint was intravaginal ejaculatory latency time (IELT) measured by chronometer. Safety and tolerability were also evaluated.

Results
Three sets of patients (672, 676 and 610), completed tests in the placebo, dapoxetine (30 mg), and dapoxetine (60 mg) groups. Dapoxetine prolonged considerably IELT (p<0·0001, all doses vs placebo). Mean IELT at baseline was 0·90 (SD 0·47) minute, 0·92 (0·50) minute, and 0·91 (0·48) minute, and at study endpoint (week 12 or final visit) was 1·75 (2·21) minutes for placebo, 2·78 (3·48) minutes for 30 mg dapoxetine, and 3·32 (3·68) minutes for 60 mg dapoxetine. Both dapoxetine doses were effective on the first dosage. The usual side effects to be reported  (30 mg and 60 mg dapoxetine, respectively) include nausea (8·7%, 20·1%), diarrhea (3·9%, 6·8%), headache (5·9%, 6·8%), and dizziness (3·0%, 6·2%).

Conclusion
It was concluded that on-demand dapoxetine is an effective and generally well tolerated treatment for individuals with mild to severe premature ejaculation issues.

By: The Lancet