Table 3. Summary of major efficacy variables at the study end pointa.
| |
Placebo (N = 351) |
10 mg Tadalafil (N = 185) |
20 mg Tadalafil (N = 510) |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| n | Baseline | End point | Change | n | Baseline | End point | Change | n | Baseline | End point | Change | |
| IIEF-EF domain (mean) | 347 | 14.6 | 16.7 | 2.0 | 181 | 13.9 | 21.9 | 7.2* | 502 | 14.9 | 23.0 | 8.3* |
| Mean per-patient 'yes' response to SEP questions (%) | ||||||||||||
| SEP2. Successful penetration | 348 | 51.3 | 55.3 | 4.0 | 181 | 43.6 | 77.3 | 26.0* | 502 | 54.2 | 82.9 | 31.5* |
| SEP3. Successful intercourse | 348 | 20.7 | 33.4 | 13.8 | 181 | 15.4 | 64.1 | 44.5* | 502 | 20.4 | 70.5 | 50.9* |
| GAQ question (%) | ||||||||||||
| Improved erections | 338 | 43.5 | 179 | 85.5* | 493 | 85.4* | ||||||
| IIEF-EF ≥ 26 at end point, n (%) | 336 | 40 (11.9) | 175 | 63 (36.0) | 489 | 222 (45.4)* | ||||||
| IEF domains (mean) | ||||||||||||
| Intercourse satisfaction | 347 | 6.2 | 8.0 | 1.7 | 181 | 5.9 | 10.2 | 3.9* | 502 | 6.6 | 10.5 | 4.2* |
| Overall satisfaction | 347 | 4.3 | 5.1 | 0.8 | 181 | 4.4 | 6.6 | 2.3* | 502 | 4.4 | 6.8 | 2.5* |
Abbreviations: GAQ, Global Assessment Question; IIEF, International Index of Erectile Function; N, number of patients randomized per treatment group; n, number of patients having both baseline and end point data; SEP, Sexual Encounter Profile.
Least squares mean end point and change reported, with the exception of GAQ and return to normal erectile function (IIEF-EF ≥ 26) results.
P < 0.001 vs. placebo.