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. 2009 Apr 20;11(4):423–433. doi: 10.1038/aja.2009.11

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.

a

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.