A Double Blind, Placebo Controlled, Randomized Trial to Evaluate the Efficacy and Tolerability of On-Demand Oral Pregablin (150 mg and 75 mg) in Treatment of Premature Ejaculation.

ABSTRACT

INTRODUCTION: Although premature ejaculation (PE) is a common sexual dysfunction, the available options for PE treatment remain unsatisfactory. AIM: To evaluate the effect of on-demand oral pregabalin on the intravaginal ejaculation latency time (IELT). METHOD: We conducted a multiarm double-blinded placebo-controlled randomized clinical trial that enrolled 120 patients with PE who were divided equally into 3 groups (A, B, and C). 4 patients were excluded, 39 patients received 150 mg pregabalin (group A), 39 patients received 75 mg pregabalin (group B), and 38 patients received placebo (group C). All patients were encouraged to engage in sexual relations twice per week for 2 weeks and to take the medication 1-2 hours before sexual intercourse. A stopwatch was used to evaluate IELT. MAIN OUTCOME MEASURE: The main outcome measure are the improvement of IELT and the reported adverse events. RESULTS: IELT significantly improved in patients who received 150 mg pregabalin, but there was no change in the other groups. CLINICAL IMPLICATIONS Most PE patients showed a significant improvement after receiving on-demand pregabalin (150 mg). STRENGTH & LIMITATIONS: The strength of this study is that it is the first randomized controlled trial to evaluate the efficacy of pregabalin in treatment of PE. The main limitations were the small number of patients, IELT was the only primary outcome of the study, and the pregabalin cap can be identified by the patient. CONCLUSION: Oral pregabalin seems to be a promising drug for additional evaluation as a new treatment for PE. More studies are needed to evaluate the suitable dose, duration, timing, and its safety profile. El Najjar MR, El Hariri M, Ramadan A, et al. A Double Blind, Placebo Controlled, Randomized Trial to Evaluate the Efficacy and Tolerability of On-Demand Oral Pregablin (150 mg and 75 mg) in Treatment of Premature Ejaculation. J Sex Med 2020;17442-446.