PMID- 19195772
OWN - NLM
STAT- MEDLINE
DCOM- 20091026
LR  - 20221207
IS  - 1873-7560 (Electronic)
IS  - 0302-2838 (Linking)
VI  - 55
IP  - 4
DP  - 2009 Apr
TI  - Dapoxetine for the treatment of premature ejaculation: results from a randomized, 
      double-blind, placebo-controlled phase 3 trial in 22 countries.
PG  - 957-67
LID - 10.1016/j.eururo.2009.01.025 [doi]
AB  - 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.
FAU - Buvat, Jacques
AU  - Buvat J
AD  - CETPARP/Le grand Hunier, Lille, France. jacques@buvat.org
FAU - Tesfaye, Fisseha
AU  - Tesfaye F
FAU - Rothman, Margaret
AU  - Rothman M
FAU - Rivas, David A
AU  - Rivas DA
FAU - Giuliano, Francois
AU  - Giuliano F
LA  - eng
SI  - ClinicalTrials.gov/NCT00229073
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20090121
PL  - Switzerland
TA  - Eur Urol
JT  - European urology
JID - 7512719
RN  - 0 (Benzylamines)
RN  - 0 (Naphthalenes)
RN  - 0 (Serotonin Uptake Inhibitors)
RN  - GB2433A4M3 (dapoxetine)
SB  - IM
CIN - Eur Urol. 2009 Apr;55(4):967-8. PMID: 19195773
MH  - Adult
MH  - Benzylamines/adverse effects/*therapeutic use
MH  - Double-Blind Method
MH  - *Ejaculation
MH  - Humans
MH  - Male
MH  - Naphthalenes/adverse effects/*therapeutic use
MH  - Selective Serotonin Reuptake Inhibitors/adverse effects/*therapeutic use
MH  - Sexual Dysfunction, Physiological/*drug therapy
EDAT- 2009/02/07 09:00
MHDA- 2009/10/27 06:00
CRDT- 2009/02/07 09:00
PHST- 2008/10/15 00:00 [received]
PHST- 2009/01/13 00:00 [accepted]
PHST- 2009/02/07 09:00 [entrez]
PHST- 2009/02/07 09:00 [pubmed]
PHST- 2009/10/27 06:00 [medline]
AID - S0302-2838(09)00037-2 [pii]
AID - 10.1016/j.eururo.2009.01.025 [doi]
PST - ppublish
SO  - Eur Urol. 2009 Apr;55(4):957-67. doi: 10.1016/j.eururo.2009.01.025. Epub 2009 Jan 
      21.