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Tolerability and adequate therapeutic dosage of oral clomipramine for the treatment of premature ejaculation: A randomized, double-blind, placebo-controlled, fixed-dose, parallel-grouped clinical study

International Journal of Impotence Research volume 30, pages 65–70 (2018)Cite this article

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Abstract

To evaluate the adequate therapeutic dosage of clomipramine 15 mg/day and clomipramine 30 mg/day in male patients with premature ejaculation (PE), this study enrolled men aged 20–65 years who met diagnostic criteria for PE including Intravaginal Ejaculation Latency Time (IELT) less than 2 min for at least 75% of their sexual intercourses. Subjects received placebo, clomipramine 15 mg, or clomipramine 30 mg prn (2~6 h before intercourse) for 4 weeks. Efficacy was assessed using fold change, percentile change, and mean change of IELT, as well as Drug Coitus Interval Time (DCIT). A total of 101 patients were randomized into the placebo group, clomipramine 15 mg group, and clomipramine 30 mg group. Analyses of fold changes of IELT in each group revealed that the IELT of both the clomipramine 15 mg group and clomipramine 30 mg group was significantly increased 4 weeks after administration than the placebo group. Adverse events were reported by 11.76, 32.35, and 57.57% of patients in the placebo group, clomipramine 15 mg group, and clomipramine 30 mg group, respectively. Most common adverse events in the clomipramine treatment groups were gastrointestinal disorders and psychiatric disorders of mild to moderate severity. On-demand regimen of clomipramine 15 mg resulted in a significant improvement in IELT and was superior to a regimen of clomipramine 30 mg in terms of risk-to-benefit ratio.

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References

  1. Laumann EO, Paik A, Rosen RC. Sexual dysfunction in the United States: prevalence and predictors. JAMA 1999;281:537–44.

    Article  CAS  PubMed  Google Scholar 

  2. Porst H, Montorsi F, Rosen RC, Gaynor L, Grupe S, Alexander J. The Premature Ejaculation Prevalence and Attitudes (PEPA) survey: prevalence, comorbidities, and professional help-seeking. Eur Urol 2007;51:816–23. discussion 824

    Article  PubMed  Google Scholar 

  3. Donatucci CF. Etiology of ejaculation and pathophysiology of premature ejaculation. J Sex Med 2006;3(Suppl 4):303–8.

    Article  CAS  PubMed  Google Scholar 

  4. Waldinger MD. The neurobiological approach to premature ejaculation. J Urol 2002;168:2359–67.

    Article  PubMed  Google Scholar 

  5. Waldinger MD, Berendsen HH, Blok BF, Olivier B, Holstege G. Premature ejaculation and serotonergic antidepressants-induced delayed ejaculation: the involvement of the serotonergic system. Behav Brain Res 1998;92:111–8.

    Article  CAS  PubMed  Google Scholar 

  6. Metz ME, Pryor JL, Nesvacil LJ, Abuzzahab F Sr, Koznar J. Premature ejaculation: a psychophysiological review. J Sex Marital Ther 1997;23:3–23.

    Article  CAS  PubMed  Google Scholar 

  7. Girgis SM, El-Haggar S, El-Hermouzy S. A double-blind trial of clomipramine in premature ejaculation. Andrologia 1982;14:364–8.

    Article  CAS  PubMed  Google Scholar 

  8. Goodman RE. An assessment of clomipramine (Anafranil) in the treatment of premature ejaculation. J Int Med Res 1980;8(Suppl 3):53–9.

    PubMed  Google Scholar 

  9. Waldinger MD, Hengeveld MW, Zwinderman AH, Olivier B. Effect of SSRI antidepressants on ejaculation: a double-blind, randomized, placebo-controlled study with fluoxetine, fluvoxamine, paroxetine, and sertraline. J Clin Psychopharmacol 1998;18:274–81.

    Article  CAS  PubMed  Google Scholar 

  10. Insel TR, Murphy DL, Cohen RM, Alterman I, Kilts C, Linnoila M. Obsessive-compulsive disorder. A double-blind trial of clomipramine and clorgyline. Arch Gen Psychiatry 1983;40:605–12.

    Article  CAS  PubMed  Google Scholar 

  11. Gur E, Lerer B, Newman ME. Chronic clomipramine and triiodothyronine increase serotonin levels in rat frontal cortex in vivo: relationship to serotonin autoreceptor activity. J Pharmacol Exp Ther 1999;288:81–7.

    CAS  PubMed  Google Scholar 

  12. Pittenger C, Bloch MH. Pharmacological treatment of obsessive-compulsive disorder. Psychiatr Clin North Am 2014;37:375–91.

    Article  PubMed  PubMed Central  Google Scholar 

  13. Foa EB, Liebowitz MR, Kozak MJ, Davies S, Campeas R, Franklin ME, et al Randomized, placebo-controlled trial of exposure and ritual prevention, clomipramine, and their combination in the treatment of obsessive-compulsive disorder. Am J Psychiatry 2005;162:151–61.

    Article  PubMed  Google Scholar 

  14. Ahlenius S, Larsson K, Svensson L, Hjorth S, Carlsson A, Lindberg P, et al Effects of a new type of 5-HT receptor agonist on male rat sexual behavior. Pharmacol Biochem Behav 1981;15:785–92.

    Article  CAS  PubMed  Google Scholar 

  15. Foreman MM, Hall JL, Love RL. The role of the 5-HT2 receptor in the regulation of sexual performance of male rats. Life Sci 1989;45:1263–70.

    Article  CAS  PubMed  Google Scholar 

  16. Waldinger MD, van De Plas A, Pattij T, van Oorschot R, Coolen LM, Veening JG, et al The selective serotonin re-uptake inhibitors fluvoxamine and paroxetine differ in sexual inhibitory effects after chronic treatment. Psychopharmacology 2002;160:283–9.

    Article  CAS  PubMed  Google Scholar 

  17. Waldinger MD, Zwinderman AH, Olivier B. SSRIs and ejaculation: a double-blind, randomized, fixed-dose study with paroxetine and citalopram. J Clin Psychopharmacol 2001;21:556–60.

    Article  CAS  PubMed  Google Scholar 

  18. Waldinger MD, Zwinderman AH, Olivier B. Antidepressants and ejaculation: a double-blind, randomized, placebo-controlled, fixed-dose study with paroxetine, sertraline, and nefazodone. J Clin Psychopharmacol 2001;21:293–7.

    Article  CAS  PubMed  Google Scholar 

  19. Ahlenius S, Heimann M, Larsson K. Prolongation of the ejaculation latency in the male rat by thioridazine and chlorimipramine. Psychopharmacology (Berl) 1979;65:137–40.

    Article  CAS  Google Scholar 

  20. Segraves RT, Saran A, Segraves K, Maguire E. Clomipramine versus placebo in the treatment of premature ejaculation: a pilot study. J Sex Marital Ther 1993;19:198–200.

    Article  CAS  PubMed  Google Scholar 

  21. Althof SE, Levine SB, Corty EW, Risen CB, Stern EB, Kurit DM. A double-blind crossover trial of clomipramine for rapid ejaculation in 15 couples. J Clin Psychiatry 1995;56:402–7.

    CAS  PubMed  Google Scholar 

  22. Haensel SM, Rowland DL, Kallan KT. Clomipramine and sexual function in men with premature ejaculation and controls. J Urol 1996;156:1310–5.

    Article  CAS  PubMed  Google Scholar 

  23. Strassberg DS, de Gouveia Brazao CA, Rowland DL, Tan P, Slob AK. Clomipramine in the treatment of rapid (premature) ejaculation. J Sex Marital Ther 1999;25:89–101.

    Article  CAS  PubMed  Google Scholar 

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Funding

The study was funded by CTC Bio, Inc. CTC Bio, Inc. was involved in the design and conduct of the study, and in data acquisition for the study.

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Authors and Affiliations

  1. Department of Urology, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea

    Sae Woong Kim

  2. Catholic Integrative Medicine Research Institute, The Catholic University of Korea, Seoul, Republic of Korea

    Sae Woong Kim, Jin Bong Choi & Su Jin Kim

  3. Catholic Fertility Care Center, Seoul St. Mary’s Hospital, The Catholic University of Korea, Seoul, Republic of Korea

    Sae Woong Kim & Su Jin Kim

  4. Department of Family Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea

    Kyung Soo Kim, Churl Min Kim & Whan Seok Choi

  5. Department of Urology, School of Medicine, Ewha Womans University, Seoul, Republic of Korea

    Dong Hyeon Lee

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  1. Sae Woong Kim
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Correspondence to Whan Seok Choi.

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Kim, S., Choi, J., Kim, S. et al. Tolerability and adequate therapeutic dosage of oral clomipramine for the treatment of premature ejaculation: A randomized, double-blind, placebo-controlled, fixed-dose, parallel-grouped clinical study. Int J Impot Res 30, 65–70 (2018). https://doi.org/10.1038/s41443-017-0011-5

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  • DOI: https://doi.org/10.1038/s41443-017-0011-5

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