Tadalafil and fluoxetine in premature ejaculation: prospective, randomized, double-blind, placebo-controlled study.

INTRODUCTION: Premature ejaculation (PE) is a common male sexual disorder. An ideal, reliable and effective treatment is desired by many men and couples affected by this condition.

AIM: Evaluate if the association of a phosphodiesterase-5 inhibitor, tadalafil, and a selective serotonin reuptake inhibitor, fluoxetine, can prolong the intravaginal ejaculatory latency time (IELT) in men with lifelong premature ejaculation.

METHODS: Sixty patients with lifelong premature ejaculation and without erectile dysfunction (ED) with IELT less than 90 s were enrolled in the protocol and randomized into 4 groups to use a combination of medications: (1) tadalafil 20 mg plus fluoxetine 90 mg, (2) fluoxetine 90 mg plus placebo, (3) tadalafil 20 mg plus placebo, and (4) two different placebo capsules (control). Before starting the medications, each man timed his IELT with a stopwatch, and likewise during the treatment period. Fluoxetine 90 mg or placebo was taken once a week plus tadalafil 20 mg or placebo within a 36-hour frame of intended sexual intercourse with a steady partner. Patients were prospectively followed for 12 weeks. One-way ANOVA was used for statistical comparisons of IELT results in each group.

RESULTS: Mean IELT before starting treatment was 51.3 +/- 23 s. With one-way ANOVA, a statistically significant difference in post-treatment IELT was seen with combination treatment compared to placebo (p < 0.001). There were increases in IELT from baseline in patients using fluoxetine plus tadalafil (49.57 +/- 25.87 to 336.13 +/- 224.77) (p < 0.001), fluoxetine (56.55 +/- 18.55 to 233.62 +/- 105.08) (p < 0.001) and tadalafil (49.26 +/- 19.43 to 186.53 +/- 159.05) (p = 0.001). The increases in each group were statistically significant compared to the placebo (49.86 +/- 19.43 to 67.82 +/- 46.18) (p = 0.042).

CONCLUSION: Fluoxetine plus tadalafil significantly increased the IELT from baseline in men with lifelong premature ejaculation when compared to placebo, tadalafil or fluoxetine.