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Dapoxetine for the treatment of premature ejaculation: results from a randomized, double-blind, placebo-controlled phase 3 trial in 22 countries.
Eur Urol. 2009 Apr; 55(4):957-67.EU

Abstract

BACKGROUND

Dapoxetine is being developed for the on-demand treatment of premature ejaculation (PE). Previous clinical trials have demonstrated its safety and efficacy.

OBJECTIVE

To evaluate the long-term efficacy and safety of dapoxetine in men with PE.

DESIGN, SETTING, AND PARTICIPANTS

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 for > or = 6 mo, with an intravaginal ejaculatory latency time (IELT) < or = 2 min in > or = 75% of intercourse episodes at baseline.

INTERVENTION

Dapoxetine 30 mg or dapoxetine 60 mg or placebo on demand (1-3 h before intercourse) for 24 wk.

MEASUREMENTS

Stopwatch-measured IELT, Premature Ejaculation Profile (PEP), Clinical Global Impression (CGI) of change, adverse events (AEs).

RESULTS AND LIMITATIONS

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 (p<0.001 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.

CONCLUSIONS

Dapoxetine significantly improved all aspects of PE and was generally well tolerated in this broad population.

Links

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Authors+Show Affiliations

Buvat J
CETPARP/Le grand Hunier, Lille, France. jacques@buvat.org
Tesfaye F
No affiliation info available
Rothman M
No affiliation info available
Rivas DA
No affiliation info available
Giuliano F
No affiliation info available

MeSH

AdultBenzylaminesDouble-Blind MethodEjaculationHumansMaleNaphthalenesSerotonin Uptake InhibitorsSexual Dysfunction, Physiological

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19195772

Clinical Trial Links

Clinical trial which this article describes

Citation

Buvat, Jacques, et al. "Dapoxetine for the Treatment of Premature Ejaculation: Results From a Randomized, Double-blind, Placebo-controlled Phase 3 Trial in 22 Countries." European Urology, vol. 55, no. 4, 2009, pp. 957-67.
Buvat J, Tesfaye F, Rothman M, et al. Dapoxetine for the treatment of premature ejaculation: results from a randomized, double-blind, placebo-controlled phase 3 trial in 22 countries. Eur Urol. 2009;55(4):957-67.
Buvat, J., Tesfaye, F., Rothman, M., Rivas, D. A., & Giuliano, F. (2009). Dapoxetine for the treatment of premature ejaculation: results from a randomized, double-blind, placebo-controlled phase 3 trial in 22 countries. European Urology, 55(4), 957-67. https://doi.org/10.1016/j.eururo.2009.01.025
Buvat J, et al. Dapoxetine for the Treatment of Premature Ejaculation: Results From a Randomized, Double-blind, Placebo-controlled Phase 3 Trial in 22 Countries. Eur Urol. 2009;55(4):957-67. PubMed PMID: 19195772.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Dapoxetine for the treatment of premature ejaculation: results from a randomized, double-blind, placebo-controlled phase 3 trial in 22 countries. AU - Buvat,Jacques, AU - Tesfaye,Fisseha, AU - Rothman,Margaret, AU - Rivas,David A, AU - Giuliano,François, Y1 - 2009/01/21/ PY - 2008/10/15/received PY - 2009/01/13/accepted PY - 2009/2/7/entrez PY - 2009/2/7/pubmed PY - 2009/10/27/medline SP - 957 EP - 67 JF - European urology JO - Eur Urol VL - 55 IS - 4 N2 - BACKGROUND: Dapoxetine is being developed for the on-demand treatment of premature ejaculation (PE). Previous clinical trials have demonstrated its safety and efficacy. OBJECTIVE: To evaluate the long-term efficacy and safety of dapoxetine in men with PE. DESIGN, SETTING, AND PARTICIPANTS: 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 for > or = 6 mo, with an intravaginal ejaculatory latency time (IELT) < or = 2 min in > or = 75% of intercourse episodes at baseline. INTERVENTION: Dapoxetine 30 mg or dapoxetine 60 mg or placebo on demand (1-3 h before intercourse) for 24 wk. MEASUREMENTS: Stopwatch-measured IELT, Premature Ejaculation Profile (PEP), Clinical Global Impression (CGI) of change, adverse events (AEs). RESULTS AND LIMITATIONS: 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 (p<0.001 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. CONCLUSIONS: Dapoxetine significantly improved all aspects of PE and was generally well tolerated in this broad population. SN - 1873-7560 UR - https://www.unboundmedicine.com/medline/citation/19195772/Dapoxetine_for_the_treatment_of_premature_ejaculation:_results_from_a_randomized_double_blind_placebo_controlled_phase_3_trial_in_22_countries_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0302-2838(09)00037-2 DB - PRIME DP - Unbound Medicine ER -