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

PURPOSE: The aim of the current trial was to assess the efficacy of on demand clomipramine 15 mg administered before sexual intercourse for the treatment of premature ejaculation.

MATERIALS AND METHODS: A total of 159 patients at 5 centers in Korea were randomly assigned to 2 groups. The first group of 53 men received placebo and the second group of 106 received clomipramine 15 mg for 12 weeks. All patients were evaluated at the beginning of the study and every 4 weeks thereafter. Patients were instructed to ingest a tablet approximately 2 to 6 hours before sexual intercourse. Efficacy was assessed by scores on the IELT (Intravaginal Ejaculation Latency Time) and the PEDT (Premature Ejaculation Diagnostic Tool).

RESULTS: Analyses of the IELT fold change in each group in the intent to treat population revealed that the IELT of the clomipramine 15 mg group was significantly increased 12 weeks after administration compared with the placebo group (mean ± SD 4.40 ± 5.29 vs 2.68 ± 2.03, p <0.05). The IELT fold change in the per protocol population also significantly differed between the clomipramine 15 mg group and the placebo group (mean 4.66 ± 5.64 vs 2.80 ± 2.19, p <0.05). There was a significant difference in the PEDT scores between the 2 groups (p <0.001). The most commonly reported adverse events were nausea in 15.7% of men and dizziness in 4.9%. Adverse events were mild to moderate in severity.

CONCLUSIONS: The results of this multicenter, randomized, double-blind, placebo controlled, fixed dose clinical phase III study suggest that administering clomipramine 15 mg on demand to treat premature ejaculation is effective and safe.