Trials in a General Erectile Dysfunction Population: In the major North American fixed-dose trial, 762 patients (mean age 57, range 20-83 years; 79% White, 13% Black, 4% Hispanic, 2% Asian and 2% Other) were evaluated. The mean baseline EF Domain scores were 13, 13, 13, and 14 for the LEVITRA 5-mg, 10-mg, 20-mg, and placebo groups, respectively. There was significant improvement (P<0.0001) at 3 months with LEVITRA (EF Domain scores of 18, 21, 21, for the 5-mg, 10-mg, and 20-mg dose groups, respectively) compared to the placebo group (EF Domain score of 15). The European trial (N=803) confirmed these results. The improvement in mean score was maintained at all doses at 6 months in the North American trial.

In the North American trial, LEVITRA significantly improved the rates of achieving an erection sufficient for penetration (SEP2) at doses of 5-mg, 10-mg, and 20-mg compared to placebo (65%, 75%, and 80%, respectively, compared to a 52% response in the placebo group at 3 months; (P<0.0001). The European trial confirmed these results.

LEVITRA demonstrated a clinically meaningful and statistically significant increase in the overall per-patient rate of maintenance of erection to successful intercourse (SEP3) (51% on 5-mg, 64% on 10-mg, and 65% on 20-mg, respectively, compared to 32% on placebo; P<0.0001) at 3 months in the North American trial. The European trial showed comparable efficacy. This improvement in mean score was maintained at all doses at 6 months in the North American trial.

Trial in Patients With ED and Diabetes Mellitus: LEVITRA demonstrated clinically meaningful and statistically significant improvement in erectile function in a prospective, fixed-dose (10 and 20-mg LEVITRA), double-blind, placebo-controlled trial of patients with diabetes mellitus (n=439; mean age 57 years, range 33-81 years; 80% White, 9% Black, 8% Hispanic, and 3% Other).

Significant improvements in the EF Domain were shown in this study (EF Domain scores of 17 on 10-mg LEVITRA and 19 on 20-mg LEVITRA compared to 13 on placebo; P<0.0001).

LEVITRA significantly improved the overall per-patient rate of achieving an erection sufficient for penetration (SEP2) (61% on 10-mg and 64% on 20-mg LEVITRA compared to 36% on placebo; P<0.0001).

LEVITRA demonstrated a clinically meaningful and statistically significant increase in the overall per-patient rate of maintenance of erection to successful intercourse (SEP3) (49% on 10-mg, and 54% on 20-mg LEVITRA compared to 23% on placebo; P<0.0001).

Trial in Patients With ED After Radical Prostatectomy: LEVITRA demonstrated clinically meaningful and statistically significant improvement in erectile function in a prospective, fixed-dose (10 and 20-mg LEVITRA), double-blind, placebo-controlled trial in post-prostatectomy patients (n=427, mean age 60, range 44-77 years; 93% White, 5% Black, 2% Other).

Significant improvements in the EF Domain were shown in this study (EF Domain scores of 15 on 10-mg LEVITRA and 15 on 20-mg LEVITRA compared to 9 on placebo; P<0.0001).

LEVITRA significantly improved the overall per-patient rate of achieving an erection sufficient for penetration (SEP2) (47% on 10-mg and 48% on 20-mg LEVITRA compared to 22% on placebo; P<0.0001).

LEVITRA demonstrated a clinically meaningful and statistically significant increase in the overall per-patient rate of maintenance of erection to successful intercourse (SEP3) (37% on 10-mg, 34% on 20-mg LEVITRA compared to 10% on placebo; P<0.0001).