IC351 (Cialis TM ) is a selective inhibitor of PDE5. The ef®cacy and safety of on-demand dosing of IC351 in men with erectile dysfunction was assessed in a multicenter, double-blind, placebocontrolled study. One hundred seventy-nine men (mean age: 56 y) were randomized to receive placebo or IC351 at doses of 2, 5, 10 or 25 mg, taken on demand over a 3-week period. The primary endpoints were change from baseline in responses to Questions 3 (Q3) and 4 (Q4) of the International Index of Erectile Function (IIEF). IC351 signi®cantly improved IIEF Q3 scores at all doses vs placebo (P 0.003). IC351 also signi®cantly improved IIEF Q4 scores in all but the 2 mg group (P 0.0003). No signi®cant changes in laboratory values, ECGs, or blood pressure were observed. The most common adverse events were headache and dyspepsia. The conclusion of this study was that on-demand IC351 at doses up to 25 mg was well tolerated and signi®cantly improved erectile function.

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