Table 3.
Effect of Vardenafil on Sexual Function
| Intention-to-Treat Group | Per-Protocol Group | |||||||
|---|---|---|---|---|---|---|---|---|
| Vardenafil (n = 27) | Placebo (n = 28) | Difference (Vardenafil − Placebo) [Mean (95% CI)] | P Value | Vardenafil (n = 20) | Placebo (n = 21) | Difference (Vardenafil − Placebo) [Mean (95% CI)] | P Value | |
| IIEF | ||||||||
| Overall score | ||||||||
| Baseline | 34.5 ± 16.2 | 34.6 ± 16.3 | 35.7 ± 17.3 | 31.0 ± 16.6 | ||||
| Week 12 | 42.9 ± 22.0 | 34.3 ± 18.2 | 7.9 (−0.6 to 16.3) | 0.07 | 43.8 ± 22.6 | 35.0 ± 18.0 | 6.0 (−3.8 to 15.8) | 0.23 |
| Erectile function | ||||||||
| Baseline | 12.7 ± 7.5 | 12.3 ± 7.7 | 13.3 ± 7.9 | 10.2 ± 7.2 | ||||
| Week 12 | 17.1 ± 9.9 | 12.6 ± 8.6 | 3.7 (−0.3 to 7.6) | 0.07 | 17.8 ± 10.0 | 12.4 ± 8.5 | 3.3 (−1.3 to 7.9) | 0.15 |
| Intercourse satisfaction | ||||||||
| Baseline | 6.0 ± 3.8 | 5.7 ± 4.1 | 6.6 ± 3.9 | 4.9 ± 4.7 | ||||
| Week 12 | 7.5 ± 4.8 | 5.3 ± 4.8 | 1.7 (−0.3 to 3.8) | 0.10 | 7.3 ± 5.2 | 5.2 ± 5.1 | 1.0 (−1.4 to 3.4) | 0.42 |
| Orgasmic function | ||||||||
| Baseline | 5.7 ± 3.3 | 5.7 ± 3.5 | 5.9 ± 3.4 | 5.6 ± 3.9 | ||||
| Week 12 | 6.2 ± 3.7 | 5.4 ± 3.6 | 0.9 (−0.8 to 2.6) | 0.29 | 6.5 ± 4.0 | 5.9 ± 3.7 | 0.6 (−1.4 to 2.6) | 0.56 |
| Overall satisfaction | ||||||||
| Baseline | 4.2 ± 2.2 | 4.5 ± 2.2 | 4.0 ± 2.4 | 4.1 ± 1.7 | ||||
| Week 12 | 5.8 ± 3.2 | 4.8 ± 2.1 | 1.1 (−0.1 to 2.2) | 0.07 | 5.7 ± 3.0 | 5.0 ± 2.1 | 0.9 (−0.4 to 2.2) | 0.16 |
| Sexual desire | ||||||||
| Baseline | 5.9 ± 1.9 | 6.4 ± 2.1 | 5.9 ± 1.8 | 6.2 ± 2.4 | ||||
| Week 12 | 6.3 ± 2.1 | 6.3 ± 2.4 | 0.4 (−0.5 to 1.3) | 0.38 | 6.5 ± 2.1 | 6.7 ± 2.4 | 0.1 (−0.9 to 1.1) | 0.85 |
± values are raw means ± SD. Baseline values include all participants. The between-group differences are the mean differences at 12 weeks, adjusted for baseline values calculated using mixed-model analysis. Per-protocol group included participants who met prespecified adherence criteria of >4 h use per night.