INTRODUCTION: The manufacturer of dapoxetine funded randomized clinical trials 
to study its effect in premature ejaculation (PE). Financial support by 
pharmaceutical companies, however, may jeopardize the neutrality of clinical 
research.
AIM: To investigate the scientific process that has been followed in dapoxetine 
treatment trials and reviews as compared to daily drug treatment trials and 
reviews with selective serotonin reuptake inhibitors (SSRIs) in men with PE.
METHODS: A search of Medline and Embase was conducted using the search terms 
"dapoxetine" or "SSRI." References of retrieved articles were searched. Only 
studies describing the use of these drugs in men with PE were included. Main 
Outcome Measures. Compared fold-increase intravaginal ejaculation latency time 
(IELT), geometric mean IELT, and adverse effect profiles between dapoxetine and 
SSRIs in PE.
RESULTS: Preclinical studies on dapoxetine, including a multicenter study 
(category A) and reviews (category B), were compared with clinical studies with 
daily conventional SSRIs in PE (category C). Categories A/B focused on 
patient-reported outcomes with less attention for the IELT. The 
ejaculation-delaying effect of dapoxetine was expressed as natural mean IELT 
rather than as geometrical mean IELT. Dapoxetine side effects were monthly 
scored. In contrast, a significant part of category C articles focused on IELT 
data, used geometric mean IELT outcomes, and one study reported the side effects 
measured 24-48 hours after drug intake using a validated questionnaire. Without 
the Food and Drug Administration approval, dapoxetine, as well as other SSRIs in 
PE, is an off-label drug for PE. However, the off-label use of dapoxetine has 
never been criticized by clinical investigators in contrast to commentaries 
against the off-label use of daily SSRI treatment in PE.
CONCLUSIONS: Manufacturer-funded drug treatment research (categories A and B) is 
advantageously treated by some authors as compared with nonfunded trials with 
daily conventional SSRIs (category C). PE drug treatment research is a young and 
dynamic field, and its development deserves transparency to its development.