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

Choi, Jin Bong; Kang, Sung Hak; Lee, Dong Hoon; Kim, Young Sik; Jeon, Joon Seong; Choi, Whan-Seok; Kim, Sae Woong

doi:10.1016/j.juro.2018.07.089

Cited by 15 publications

(9 citation statements)

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“…These include subgroup analysis of impact differences, meta-regression of duration and sensitivity analysis of research features. & Shamloul, 2006;Arafa & Shamloul, 2007;Athanasios, Polyanthi, & George, 2007;Atmaca, Kuloglu, Tezcan, & Semercioz, 2002;Atmaca, Kuloglu, Tezcan, Ustundag, & Semercioz, 2003;Aversa et al, 2009;Bar-Or, Salottolo, Orlando, Winkler, & Tramadol, 2012;Biri et al, 1998;Busato & Galindo, 2004;Buvat, Tesfaye, Rothman, Rivas, & Giuliano, 2009;Carson & Wyllie, 2010;Choi et al, 2019;Dinsmore et al, 2007;Dinsmore & Wyllie, 2009;Farnia, Raisi, Mohsen, Atharikia, & Ghafur, 2009;Gameel et al, 2013;Hamidi-Madani et al, 2018;Homayuonfar et al, 2018;Hosseini & Yarmohammadi, 2007;Kaufman et al, 2009;Kaynar, Kilic, & Yurdakul, 2012;Khan & Rasaily, 2013;Kim et al, 2018;Lee et al, 2013;Mathers, Klotz, Roth, Lümmen, & Sommer, 2009;Mattos, Marmo Lucon, & Srougi, 2008;C. McMahon et al, 2010;McMahon, 1998;Moudi & Kasaeeyan, 2016;Novarett, Pompeo, & Arap, 2002;Otunctemur et al, 2014;Polat, Ozbek, Otunctemur, Ozcan, & Simsek, 2015;Pryor et al, 2006;Safarinejad, 2006;Safarinejad & Hosseini, 2006;Sahin et al, 2016;…”

Section: Discussionmentioning

confidence: 99%

Comparative efficacy and safety of drug treatment for premature ejaculation: A systemic review and Bayesian network meta‐analysis

et al. 2020

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To assess the comparative efficacy and safety of drug treatments for premature ejaculation. A systemic review and Bayesian network meta‐analysis were executed on randomised controlled trials of drug interventions for premature ejaculation. Intravaginal ejaculation latency time and related adverse effects were outcome measures. A total of 44 RCTs with 11,008 patients were included in our NMA. In therapy <8 weeks, the ranking of drug efficacy was topical creams >selective serotonin reuptake inhibitor (SSRI)+ phosphodiesterase 5 inhibitor (PDE5i) > PDE5i > sertraline > clomipramine > paroxetine > dapoxetine 60 milligram (mg) > dapoxetine 30 mg > fluoxetine>citalopram > duloxetine>placebo. In therapy ≥ 8 weeks, the ranking of drug efficacy was SSRI + PDE5i > topical creams > paroxetine > tramadol > PDE5i > fluoxetine > dapoxetine 60 mg > dapoxetine 30 mg > clomipramine>citalopram > placebo. For total adverse events, clomipramine, dapoxetine 30 mg, dapoxetine 60 mg, paroxetine, PDE5i, SSRI + PDE5i and tramadol had a higher risk than placebo. In conclusion, in ≥8 weeks of therapy, the drug combination of SSRI + PDE5i was the most effective PE therapy. In <8 weeks of therapy, the efficacy of local anaesthetics was best. All drug treatments were ranked better than placebo. In general, drugs with better effects had more obvious side effects.

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Section: Discussionmentioning

confidence: 99%

Comparative efficacy and safety of drug treatment for premature ejaculation: A systemic review and Bayesian network meta‐analysis

et al. 2020

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“…8 studies, including 252 patients receiving clomipramine and 201 patients receiving the placebo, reported a higher risk of adverse events in the nervous system with clomipramine than with the placebo treatment (RR: 4.07, 95% CI: 2.41e6.86, P < .0001). 16,27,28,30,31,34,35,38 No heterogeneity was observed (I 2 ¼ 0%) in the outcome analysis. The adverse events in other systems are summarized in Table 2 and demonstrated in Figure S4 to S9.…”

Section: Ielt Of Clomipramine Vs Placebomentioning

confidence: 97%

“…27,29,30,32e34 No dose-dependent effects on adverse events were observed (estimate 0.0074, 95% CI: À0.0284 to 0.0433, P ¼ .6850; Figure S11) as determined through meta-regression analysis of 9 studies. 16,27,28,30,31,34,35,38 However, a slightly increasing slope is evident. To determine the balance of the IELT and adverse events, 2 regression plots were overlaid through postprocessing ( Figure 5).…”

Section: Dose-dependent Effects Of Clomipramine Vs Placebo Treatmentsmentioning

confidence: 98%

Tolerability and Optimal Therapeutic Dosage of Clomipramine for Premature Ejaculation: A Systematic Review and Meta-Analysis

Hung

Kang

et al. 2020

Sexual Medicine

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Introduction Clomipramine is effective in treating premature ejaculation, a common form of male sexual dysfunction that affects individual's mental health and quality of life, but its optimal dosage remains controversial. Aim In this systematic review and meta-analysis, we aimed to evaluate the efficacy, safety, and optimal dose of clomipramine for treating premature ejaculation among men. Methods Eligible studies of PubMed, Embase, and Web of Science were identified from the date of inception to June 21, 2020. We conducted the study according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Data of the study characteristics, intravaginal latency ejaculatory time (IELT), adverse events, success rate, and satisfaction rate of clomipramine vs placebo were extracted and analyzed. The risk ratio and mean difference were used for quantitatively analyzing binary outcomes and continuous outcomes. The standardized mean difference was applied to the outcome of satisfaction rate. The Mantel–Haenszel method was used for meta-analysis under random-effects model. To assess dose effect of clomipramine, a meta-regression analysis was performed. Main Outcome Measures The primary outcomes were the IELT and adverse events, and the secondary outcomes were the success rate and satisfaction rate of clomipramine treatment relative to the placebo. Results A total 14 randomized controlled trials with 710 patients were included for quantitative analysis. Clomipramine significantly increased the IELT compared with the placebo (mean difference: 1.47, 95% CI: 0.73–2.21). However, clomipramine was associated with higher risks of overall adverse events and adverse events in the nervous and respiratory systems. Significant dosage effects on the IELT (estimate: 0.0637, 95% CI: 0.0074–0.12) and a slightly increasing slope on adverse events were revealed. Conclusion Clomipramine increased the IELT and yielded greater satisfaction than the placebo, and the higher dose results in a superior IELT without leading to higher risk of adverse events under a dosage of 50-mg clomipramine.

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“…Yaşam boyu PE'li 539 olgu ve partnerlerini kapsayan iki adet çok merkezli faz 3 çalışmada ötektik lidokain/prilokain sprey'in İVEZ süresinin geometrik ortalamasını bazal değer olan 0,6 dakikadan 3,8 dakikaya uzattığı gösterilmiştir. [25] İVEZ süresindeki artış oranı plaseboda 1,7 kat ve ilaç grubunda 6,3 kat bulunmuştur. Üç aylık tedavi sonucunda da İVEZ'deki uzama devam etmektedir.…”

Section: öTektik Lidokain/prilokain Doz Ayarlamalı Spreyunclassified

Prematür ejakülasyon tedavisinde güncel yaklaşımlar

Aşçı¹

2020

Androl Bul

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Prematür ejakülasyon (PE) yaygın bir erkek cinsel işlev bozukluğu olmasına rağmen, patofizyolojisi tam olarak anlaşılamamıştır. Hastalar genellikle sorunları için tedavi aramazlar ve hekimlerin çoğu da PE'nin etkili tedavisi konusunda deneyimli değildir. Sonuç olarak hastalar yanlış tanı alabilir veya uygun olmayan tedavi görebilir. Uluslararası Cinsel Tıp Derneği (ISSM) yaşam boyu, kazanılmış, değişken ve PE benzeri ejakülasyon bozukluğu (sübjektif PE) şeklinde dört tip PE tanımlamıştır. [1] PE ABSTRACT OBJECTİVES: To review current developments in the treatment of prematüre ejaculation MATERIAL AND METHODS: Research studies, reviews, related texts related to premature ejaculation therapy obtained from electronic academic databases such as Web of Science, Pubmed, Scopus and Google Scholar were reviewed. RESULTS: The European Medicine Agency (EMA) recommends shortacting SSRI dapoxetine and eutectic lidocaine/prilocaine metered-dose aerosol spray for the on-demand treatment of PE. PDE5i drugs alone or in combination with SSRIs are more effective in the treatment of lifelong PE. Topical anesthetics and combinations of PD5i or SSRI may be effective in the treatment of anteportal PE. Pharmacological therapies combined with psychosexual/behavioral therapies may be useful in the treatment of acquired PE. CONCLUSIONS: Pharmacotherapy should be the first option for lifelong PE. Combined pharmacological therapies with peripheral and central effects may be beneficial, especially in men with anteportal PE. Eutectic lidocaine/prilocaine metered-dose aerosol spray may be an alternative for off-label SSRI treatment.

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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

Abstract: 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.

Cited by 15 publications

References 0 publications

Comparative efficacy and safety of drug treatment for premature ejaculation: A systemic review and Bayesian network meta‐analysis

Comparative efficacy and safety of drug treatment for premature ejaculation: A systemic review and Bayesian network meta‐analysis

Tolerability and Optimal Therapeutic Dosage of Clomipramine for Premature Ejaculation: A Systematic Review and Meta-Analysis

Prematür ejakülasyon tedavisinde güncel yaklaşımlar

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