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LEVITRA (VARDENAFIL): CLINICAL STUDIES

Levitra (Vardenafil) was evaluated in four major double-blind, randomized, placebo-controlled, fixed-dose, parallel design, multicenter trials in 2431 men aged 20-83 (mean age 57 years; 78% White, 7% Black, 2% Asian, 3% Hispanic and 10% Other/Unknown). The doses of Levitra in these studies were 5 mg, 10 mg, and 20 mg. Two of these trials were conducted in the general ED population and two in special ED populations (one in patients with diabetes mellitus and one in post-prostatectomy patients). Levitra (Vardenafil) tablets were dosed without regard to meals on an as needed basis in men with erectile dysfunction (ED), many of whom had multiple other medical conditions. The primary endpoints were assessed at 3 months.

Primary efficacy assessment in all four major trials was by means of the Erectile Function (EF) Domain score of the validated International Index of Erectile Function (IIEF) Questionnaire and two questions from the Sexual Encounter Profile (SEP) dealing with the ability to achieve vaginal penetration (SEP2), and the ability to maintain an erection long enough for successful intercourse (SEP3).

In all four fixed-dose efficacy trials, Levitra showed clinically meaningful and statistically significant improvement in the EF Domain, SEP2, and SEP3 scores compared to placebo. The mean baseline EF Domain score in these trials was 11.8 (scores range from 0-30 where lower scores represent more severe disease). Levitra (5 mg, 10 mg, and 20 mg) was effective in all age categories ( < 45, 45 to < 65, and >= 65 years) and was also effective regardless of race (White, Black, Other).

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, 14 for the Vardenafil Hydrochloride (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 (total 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, Vardenafil Hydrochloride (Levitra) tablets 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 (Vardenafil HCl) 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; 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 (Vardenafil HCl) tablets 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).

Vardenafil (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, 54% on 20 mg Levitra compared to 23% on placebo; p < 0.0001).

Trial in Patients with ED after Radical Prostatectomy

Vardenafil (Levitra) tablets 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). This medication 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 (Vardenafil Hydrochloride) 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).

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