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The Efficacy and Safety of Daily Use of Tadalafil in Treatment of Premature Ejaculation: A Systematic Review and Meta-Analysis

Shi-Kai Zhao, Jian-Kun Zhang, Yuanshan Cui, Yun-Bo Ma, Huilei Yan

American Journal of Men's Health, 2025

397 participants · 1 citation

Abstract

The purpose of this meta-analysis was to evaluate the efficacy and safety of the once-daily use of 5 mg tadalafil in the treatment of patients with premature ejaculation. The databases MEDLINE/PubMed, EMBASE, and Cochrane Library from January 1980 until December 2024 were searched to identify randomized controlled trials (RCTs) that referred to the use of tadalafil for the treatment of premature ejaculation. A systematic review and meta-analysis was conducted. Five publications involving 397 patients were included in the meta-analysis. No statistically significant difference was identified between tadalafil and placebo for intravaginal ejaculatory latency time (IELT; mean difference [MD] = 68.43; 95% confidence interval [CI] = [−12.59 to 149.45]; p = .10) and Arabic index of premature ejaculation (AIPE; MD = 11.44; 95% CI = [−11.79, 34.66]; p = .33). Tadalafil appeared to improve the score of the premature ejaculation diagnostic tool (PEDT; MD = −0.30; 95% CI = [−0.57, −0.03]; p = .03). In terms of adverse events, the tadalafil group was significantly higher than the placebo group for headache (odds ratio [ OR ] = 16.06, 95% CI = [3.80, 67.94], p = .0002), back pain and myalgia ( OR = 21.76, 95% CI = [4.17, 113.53], p = .0003), flushing ( OR = 6.05, 95% CI = [1.05, 34.92], p = .04), and dyspepsia ( OR = 10.27, 95% CI = [1.90, 55.96], p < .007). Our meta-analysis indicates that the once-daily use of 5 mg tadalafil had no statistically significant effect in the treatment of…

How strong is the evidence?

Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 397 participants or records.

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