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Efficacy and Safety of On-Demand Clomipramine for the Treatment of Premature Ejaculation: A Multicenter, Randomized, Double-Blind, Phase III Clinical Trial



Efficacy and Safety of On-Demand Clomipramine for the Treatment of Premature Ejaculation: A Multicenter, Randomized, Double-Blind, Phase III Clinical Trial



Journal of Urology 2018



The aim of the present trial is to assess the efficacy of on-demand clomipramine 15 mg administered before sexual intercourse for the treatment of premature ejaculation (PE). A total of 159 patients at five centers in Korea were randomly assigned into two groups. The first group received placebo (n=53) and the second group received clomipramine 15 mg (n=106) for 12 weeks. All patients were evaluated at the beginning of the study and every 4 weeks. Patients were instructed to take a tablet approximately 2-6 hours before sexual intercourse. Efficacy was assessed using Intravaginal Ejaculation Latency Time (IELT) and Premature Ejaculation Diagnostic Tool (PEDT) scores. Analyses of fold change of IELT in each group in the Intention-to-Treat (ITT) population revealed that the IELT of the clomipramine 15 mg group was significantly increased 12 weeks after administration compared with the placebo group (4.40±5.29 vs. 2.68±2.03, p <0.05). Fold change of IELT in the Per Protocol (PP) population was also significantly different between the clomipramine 15 mg group and the placebo group (4.66±5.64 vs. 2.80±2.19, p <0.05). There was a significant difference in the PEDT scores between the two groups (p <0.001). The most commonly reported adverse events were nausea (15.7%) and dizziness (4.9%) and were mild to moderate in severity. Results of this multicenter, randomized, double-blind, placebo-controlled, fixed-dose clinical phase III study suggest that use of on-demand clomipramine 15 mg for treatment of PE is effective and safe.

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Accession: 060715981

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PMID: 30086277


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