Efficacy and Safety of Combination Therapy with Tadalafil and Sertraline for Premature Ejaculation: A Double-blind Randomized Controlled Trial

Abstract

Background and Objective: Selective serotonin reuptake inhibitors (SSRIs) are effective in patients with premature ejaculation (PE), but the effect of combination therapy with tadalafil as a phosphodiesterase-5 inhibitor (PDE5I) and sertraline (an SSRI) in these patients has been less studied. The aim of this study was to evaluate the safety and efficacy of tadalafil with sertraline compared with sertraline and placebo. Materials and Methods: 107 patients with lifelong PE and no erectile dysfunction (ED) and an intravaginal ejaculation latency time (IELT) of less than 60s were treated for 6 weeks. Subjects were randomly divided into two groups: the placebo group (n=51) and the tadalafil group (n=51), who received sertraline 50 mg daily plus placebo on demand or sertraline 50 mg daily plus tadalafil 10 mg on demand . Premature ejaculation profile (PEP) and IELT were used to evaluate PE. The change in mean IELT, mean change in all four measures of PEP, and adverse effects in 2 groups were recorded. Results: Mean IELT before and after treatment was 35 .29sand 87 .55s, respectively, in the placebo group (P<0 ,0001) and 40 .1s and 153.63s, respectively, in the tadalafil group (P<0 .0001). Mean IELT improved significantly in the tadalafil group compared with the placebo group (113.53s vs. 52.25s, P<0.0001). All four measures of PEP scores also improved in the tadalafil group compared with the placebo group. Drug-related adverse events occurred more frequently in group B than in group A. Conclusion: Combination therapy with tadalafil and sertraline in the treatment of premature ejaculation is more effective than sertraline alone despite more side effects.