Combination of Sertraline and Sildenafil versus Sertraline Monotherapy in the Treatment of Acquired Premature Ejaculation without Concomitant Diseases

Objective: To determine the efficacy and safety of sertraline monotherapy and combination therapy with sertraline and sildenafil in the treatment of APE without concomitant diseases. Methods: The study was conducted in 120 outpatients diagnosed with APE but without concomitant diseases. These patients were randomly divided into two groups: group A was treated with 50 mg sertraline daily; group B was treated with 50 mg sertraline daily and 50 mg sildenafil as needed. Assessment of the efficacy and safety of the two therapies was performed after 4 and 8 weeks. Patient or partner reports of Intravaginal Ejaculatory Latency Time (IELT), Premature Ejaculation Profile (PEP), Clinical Global Impression of Change (CGIC), and Treatment-Emergent Adverse Events (TEAEs) were assessed in this study. All the assessments were compared in the two groups after the treatment period. The efficacy was assessed by IELT, PEP and CGIC. On the other hand, safety was assessed by TEAEs. Results: 112 participants completed the study voluntarily. The two groups were similar regarding demographics. At the end of study period, both groups had significant improvements in IELT and PEP measures compared with pretreatment (P<0.001). Compared with group A, group B had significantly greater values of IELT (7.20 ± 2.93 vs. 5.04 ± 2.79), PEP measures, and CGIC (subjects reporting at least ‘better’: 58.2% vs. 35.8%) (P<0.05 for all). Adverse effects including headache, flushing, etc. were found in both groups, and the total incidence was higher in group B than group A (31.7% vs. 23.3%, respectively), but the difference was not significant. All the adverse effects were mild and tolerated. Conclusion: Both sertraline monotherapy and combination therapy with sildenafil and sertraline were efficacious and safe in the treatment of APE without concomitant diseases. The combination therapy had a higher efficacy than sertraline monotherapy without more adverse effects.