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


OBJECTIVE
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).


CONCLUSIONS
Fluoxetine plus tadalafil significantly increased the IELT from baseline in men with lifelong premature ejaculation when compared to placebo, tadalafil or fluoxetine.
Mattos
Rogerio M
RM
Universidade de São Paulo, Institute of Urology, São Paulo, Brazil. mattosrio@yahoo.com.br
Marmo Lucon
Antonio
A
Srougi
Miguel
M
D000328:Adult; D002243:Carbolines / Q000627:therapeutic use*; D004311:Double-Blind Method; D004542:Ejaculation / Q000187:drug effects*; D005473:Fluoxetine / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010726:Phosphodiesterase Inhibitors / Q000627:therapeutic use*; D011446:Prospective Studies; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D012735:Sexual Dysfunction, Physiological / Q000188:drug therapy*; D000068581:Tadalafil; D013997:Time Factors
D002243:Carbolines; D005473:Fluoxetine; D010726:Phosphodiesterase Inhibitors; D017367:Selective Serotonin Reuptake Inhibitors; D000068581:Tadalafil