This off label randomized placebo controlled study was designed to investigate the efficacy of duloxetine a new potent dual inhibitor of serotonin and norepinephrine reuptake (SNRI) in the treatment of patients with PE.

Men with diagnosed PE (n=25) with an intravaginal ejaculation latency time (IELT) less then one minute were enrolled and randomized in to two groups for duloxetine 30mg (DLX; n=16) or placebo (PL; n=9), administered once-daily, for the period up to 6 weeks. IELT has been considered before, after the second week and at the end of the treatment course. Erectile function was evaluated by means of SHIM questionnaire before and after the treatment period.

Both groups were comparable by age (35±10 vs. 40±12), pretreatment IELT (DLX group 0,8±0,3 min; PL group 0,9±0,2 min), and SHIM scores (20,9± 1,6 vs. 20,1± 2,5). After 2 weeks and 6 weeks of drug administration in DLX group a significant improvement in IELT up to 10 fold (p<0,000) was observed (8,0 ± 4,0 and 9,3 ±3,3 minutes accordingly), while in placebo group the mean IELT has slightly, but not significantly increased at the second week (1,4±0,7 min) and decreased after 6 weeks to 0,95±0,4 min. Significant improvement in SHIM score has been noted in DLX group (pre vs. post-treatment 19,7 ± 1,6 vs. 22,8 ± 1,6; p< 0,005).

An SNR inhibitor duloxetine appears as highly effective treatment option in patients with PE in comparison to placebo, without erectile function disturbance, and can be recommended for larger controlled studies.