The world journal of men's health · 2026
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.
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Kim Jae Heon, Lee Won Ki, Kam Sung Chul, Kim Soo Woong, Kim Tae Hyo, Shin Hong Seok, Oh Chul Young, Lee Seung Wook, Lee Seung Hwan, Ryu Ji-Kan, Park Heung Jae, Kim Sae Woong, Moon Du Geon
Аннотация
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: 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: In the full analysis set, mean IELT increased by 191.6±12.7, 162.5±12.1, and 272.6±19.2 seconds in groups A, B, and C, respectively (all p<0.001 vs. baseline). CDFR0812 demonstrated significantly greater IELT improvement over clomipramine (+81.0±23.0 seconds; 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%, 24.1%, and 32.2% of groups A, B, and C, respectively (p=0.062); all were mild to moderate, and no serious adverse drug reactions were reported.
CONCLUSIONS: On-demand CDFR0812 demonstrated significantly greater efficacy compared with either active monotherapy while maintaining a comparable safety profile. As this trial employed an active-controlled design without a placebo arm, the observed superiority is relative to clomipramine and sildenafil monotherapy rather than to no treatment. On-demand CDFR0812 may represent a promising additional on-demand treatment option for men with PE and normal erectile function; confirmation in placebo-controlled trials is warranted.
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: In the full analysis set, mean IELT increased by 191.6±12.7, 162.5±12.1, and 272.6±19.2 seconds in groups A, B, and C, respectively (all p<0.001 vs. baseline). CDFR0812 demonstrated significantly greater IELT improvement over clomipramine (+81.0±23.0 seconds; 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%, 24.1%, and 32.2% of groups A, B, and C, respectively (p=0.062); all were mild to moderate, and no serious adverse drug reactions were reported.
CONCLUSIONS: On-demand CDFR0812 demonstrated significantly greater efficacy compared with either active monotherapy while maintaining a comparable safety profile. As this trial employed an active-controlled design without a placebo arm, the observed superiority is relative to clomipramine and sildenafil monotherapy rather than to no treatment. On-demand CDFR0812 may represent a promising additional on-demand treatment option for men with PE and normal erectile function; confirmation in placebo-controlled trials is warranted.