Efficacy and Safety of On-Demand Therapy with Clomipramine/Sildenafil Combination Compared to Clomipramine or Sildenafil Alone in Patients with Premature Ejaculation: A Multicenter Phase 3 Randomized Controlled Trial
Abstract
Purpose: Purpose: Premature ejaculation (PE) is a prevalent male sexual disorder with limited on-demand pharmacological options.We evaluated the efficacy and safety of on-demand clomipramine 15 mg plus sildenafil 50 mg (CDFR0812) compared with either agent alone in men with PE and normal erectile function.Materials and Methods: Materials and Methods: This was a prospective, randomized, double-blind, active-controlled, three-arm, multicenter phase 3 trial conducted from October 2019 to April 2022.A total of 795 men with PE and normal erectile function were randomized 1:1:1 to clomipramine 15 mg (group A, n=264), sildenafil 50 mg (group B, n=266), or CDFR0812 (group C, n=264) on demand for 12 weeks.The primary endpoint was the change in stopwatch-measured intravaginal ejaculatory latency time (IELT) from baseline to week 12. Secondary endpoints included the Premature Ejaculation Profile (PEP), Premature Ejaculation Diagnostic Tool, and Patient Global Impression of Change (PGIC).Adverse events (AEs) were systematically recorded.Results: Results: In the full analysis set, mean IELT increased by 191.6±12.7,162.5±12.1, and 272.6±19.2seconds in groups A, B, and C, respectively (all p<0.001 vs. baseline).CDFR0812 demonstrated significantly greater IELT improvement over clomipramine (+81.0±23.0seconds; p<0.001) and sildenafil (+110.1±22.5 seconds; p<0.001).PEP and PGIC responder rates were significantly higher in group C than in groups A and B (all p≤0.037).AEs occurred in 24.6%,…
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: 795 participants or records.
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