Table 3. Randomized controlled trials of dapoxetine (96,100).
| Study (clinical registration number) | Study description | Treatment duration | Randomized subjects | Inclusion criteria | Results |
|---|---|---|---|---|---|
| U.S. study (NCT00211094) (97) | Multicenter, double-blind, randomized, placebo-controlled, parallel-group | 12 weeks | 1,294 | • ≥18 years of age | Mean IELT increased from 0.9, 0.92 and 0.91 minutes to 1.75, 2.78 and 3.32 minutes for placebo, 30 and 60 mg dapoxetine respectively |
| • In a monogamous, heterosexual relationship for ≥6 months | |||||
| • Met DSM-IV-TR criteria for PE for ≥6 months | |||||
| • IELT ≤2 minutes in ≥75% of intercourse episodes during a 2-week baseline period | |||||
| • PE severity rated as at least “moderate” | |||||
| U.S. study (NCT00211107) (97) | Multicenter, double-blind, randomized, placebo-controlled, parallel-group | 12 weeks | 1,320 | • Same as above | Same as above |
| International study (NCT00229073) (98) |
Multi-center, double-blind, randomized, placebo-controlled, parallel-group study conducted in 22 countries, primarily in Europe and South America | 24 weeks | 1,162 | • Same as above except: | Mean geometric IELT increased from 0.7 minutes to 1.1, 1.8 and 2.3 minutes for placebo, 30 and 60 mg dapoxetine respectively |
| • IELT of ≤2 minutes in ≥75% of intercourse episodes during a 4-week baseline period | |||||
| • At least “moderate” PE-related distress or interpersonal difficulty | |||||
| Asia-Pacific study (NCT00210704) (95) | Multicenter, double-blind, randomized, placebo-controlled, parallel-group | 12 weeks | 1,067 | • Same as International study | Mean geometric IELT increased from 0.9 minutes to 1.8, 2.7, and 3.1 minutes for placebo, 30 and 60 mg dapoxetine respectively |
| North American study (NCT00210613) (99) | Multicenter, double-blind, randomized, placebo-controlled, parallel-group | 9 weeks | 1,238 | • Same as International study except no IELT Criterion | Dapoxetine reduced the personal distress and interpersonal difficulty associated with PE |
Abbreviations: DSM-IV-TR, Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision; IELT, intravaginal ejaculatory latency time; MADRS, Montgomery-Åsberg Depression Rating Scale; PE, premature ejaculation.