Table 2.
Results of dapoxetine phase II and III studies [Buvat et al. 2009; Hellstrom et al. 2004, 2005; Kaufman et al. 2009; McMahon et al. 2010; Pryor et al. 2006].
| Phase II studies |
Phase III studies (pooled) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Study 1 [Hellstrom et al. 2005] | Study 2 [Hellstrom et al. 2004] | Studies 1–5 [Buvat et al. 2009; Kaufman et al. 2009; McMahon et al. 2010; Pryor et al. 2006] | |||||||
| Age range (years) | 18–60 | 18–65 | 18–82 | ||||||
| Inclusion criteria, IELT | DSM-IV TR, <2 min estimated | DSM-IV TR, <2 min by stopwatch | DSM-IV TR, <2 min by stopwatch | ||||||
| Number of subjects | 157 | 166 | 6081 | ||||||
| Treatment period | 4 weeks per treatment | 2 weeks per treatment | 9-24 weeks, parallel, fixed dose | ||||||
| Washout period | None | 72 hours | None | ||||||
| Dapoxetine dose (mg) | 20 (n = 145) | 40 (n = 141) | Placebo (n = 142) | 60 (n = 144) | 100 (n = 155) | Placebo (n = 145) | 30 (n = 1613) | 60 mg (n = 1611) | Placebo (n = 1608) |
| Mean baseline IELT | 1.34 | 1.34 | 1.34 | 1.01 | 1.01 | 1.01 | 0.9 | 0.9 | 0.9 |
| Mean treatment IELT | 2.72* | 3.31† | 2.22 | 2.86† | 3.24† | 2.07 | 3.1† | 3.6† | 1.9 |
| IELT fold increase | 2.0 | 2.5 | 1.7 | 2.9 | 3.2 | 2.0 | 2.5 | 3.0 | 1.6 |
| ‘Good/very good’ control | |||||||||
| Baseline (%) | – | – | – | – | – | – | 0.3 | 0.6 | 0.5 |
| Study end (%) | – | – | – | – | – | – | 11.2† | 26.2† | 30.2 |
| ‘Good/very good’ satisfaction | |||||||||
| Baseline (%) | – | – | – | – | – | – | 15.5 | 14.7 | 15.5 |
| Study end (%) | – | – | – | – | – | – | 24.4† | 37.9† | 42.8 |
| ‘Quite a bit/extreme’ personal distress | |||||||||
| Baseline (%) | – | – | – | – | – | – | 73.5 | 71.3 | 69.7 |
| Study end (%) | – | – | – | – | – | – | 41.9† | 28.2† | 22.2 |
| ‘Quite a bit/extreme’ interpersonal distress | |||||||||
| Baseline (%) | – | – | – | – | – | – | 38.5 | 38.8 | 36.1 |
| Study end (%) | – | – | – | – | – | – | 23.8† | 6.0† | 12.3 |
| Discontinuation due to adverse event | 0 | 2 | 0 | 0 | 9 | 1 | 3.5 | 8.8 | 1.0 |
*
p = 0.042, †p < 0.0001 versus placebo.
DSM-IV TR, Diagnostic and Statistical Manual of Mental Disorders, 4th edition revised; IELT, intravaginal ejaculation latency time.