Dapoxetine for the Treatment of Premature Ejaculation: Results from a Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial in 22 Countries
| Autor: | Margaret Rothman, Fisseha Tesfaye, François Giuliano, David Rivas, Jacques Buvat |
|---|---|
| Rok vydání: | 2009 |
| Předmět: |
Adult
Male Benzylamines medicine.medical_specialty Randomization Urology Population Naphthalenes Placebo Double-Blind Method Internal medicine Premature ejaculation Humans Medicine Ejaculation education Gynecology education.field_of_study business.industry Dapoxetine Clinical trial Sexual Dysfunction Physiological Clinical Global Impression Intravaginal ejaculation latency time medicine.symptom business Selective Serotonin Reuptake Inhibitors medicine.drug |
| Zdroj: | European Urology. 55:957-968 |
| ISSN: | 0302-2838 |
| DOI: | 10.1016/j.eururo.2009.01.025 |
| Popis: | Dapoxetine is being developed for the on-demand treatment of premature ejaculation (PE). Previous clinical trials have demonstrated its safety and efficacy.To evaluate the long-term efficacy and safety of dapoxetine in men with PE.This randomized, double-blind, parallel-group, placebo-controlled, phase 3 trial, conducted in 22 countries, enrolled men (N=1162)or = 18 yr of age who met the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision criteria for PE foror = 6 mo, with an intravaginal ejaculatory latency time (IELT)or = 2 min inor = 75% of intercourse episodes at baseline.Dapoxetine 30 mg or dapoxetine 60 mg or placebo on demand (1-3 h before intercourse) for 24 wk.Stopwatch-measured IELT, Premature Ejaculation Profile (PEP), Clinical Global Impression (CGI) of change, adverse events (AEs).The study was completed by 618 men. Mean average IELT increased from 0.9 min at baseline (all groups) to 1.9 min, 3.2 min, and 3.5 min with placebo and dapoxetine 30 mg and dapoxetine 60 mg, respectively, at study end point; geometric mean IELT increased from 0.7 min at baseline to 1.1 min, 1.8 min, and 2.3 min, respectively, at study end point. All PEP measures and IELTs improved significantly with dapoxetine versus placebo at week 12 and week 24 (p0.001 for all). The most common AEs were nausea, dizziness, diarrhea, and headache. AEs led to discontinuation in 1.3%, 3.9%, and 8.2% of subjects with placebo and dapoxetine 30 mg and dapoxetine 60 mg, respectively. Limitations of this study included the exclusion of men who were not in long-term monogamous relationships.Dapoxetine significantly improved all aspects of PE and was generally well tolerated in this broad population. |
| Databáze: | OpenAIRE |
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