Comparative evaluation of safety and efficacy of dapoxetine, silodosin, and citalopram in the management of premature ejaculation: a randomized clinical trial
Abstract
BACKGROUND: Premature ejaculation (PE) is a prevalent male sexual dysfunction with limited comparative data on pharmacological treatments. This randomized clinical trial aimed to evaluate the efficacy and safety of four active pharmacological interventions for lifelong PE.
METHODS: A prospective randomized trial was conducted from June 2024 to March 2025 at Beni-Suef University Hospital. Four hundred eligible patients diagnosed with lifelong PE were randomly allocated to one of four active treatment groups (n = 100 per group): (1) citalopram 20 mg/day, (2) silodosin 4 mg/day, (3) dapoxetine 30 mg on-demand (1-3 h before intercourse), or (4) dapoxetine 30 mg daily. The primary outcome was the change in intravaginal ejaculatory latency time (IELT) measured by stopwatch. Secondary outcomes included changes in the Premature Ejaculation Profile Questionnaire (PEPQ) scores and the incidence of treatment-emergent adverse events. Statistical analysis was performed using ANOVA with post-hoc tests for continuous variables and chi-square tests for categorical data.
RESULTS: All four treatment groups demonstrated significant within-group improvements in IELT from baseline (p < 0.001 for all). The citalopram group exhibited the greatest mean IELT increase (from 110.4 ± 31.5s to 391.2 ± 45.9s; 260% median gain), outperforming the daily dapoxetine (220%), on-demand dapoxetine (197%), and silodosin (149.5%) groups. Improvements in PEPQ scores mirrored the IELT findings, with citalopram…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 450 participants or records.
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