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Tadalafil at doses of 2 to 100 mg has been evaluated in 16 clinical studies involving 3250 patients. Tadalafil 10 mg and/or 20 mg, taken as needed up to once daily, was compared to placebo in 6 primary efficacy studies (5 in general ED population, 1 in patients with diabetes). Seven hundred and twenty four (724) patients received tadalafil 10 mg or 20 mg and 379 patients received placebo in these randomised, double-blinded, parallel-group studies. Patients were free to choose the time interval between dose administration and the time of sexual attempts. Food and alcohol intake were not restricted. The studies were designed in this manner in order to allow for convenience and dosing flexibility for the patient and partner.

Tadalafil is effective in treating ED in patients with diabetes. Patients with diabetes (n=451) were included in all primary efficacy studies, one of which specifically assessed tadalafil only in ED patients with Type 1 or Type 2 diabetes. Tadalafil produced statistically significant improvement in erectile function and sexual satisfaction. In these studies, 68% of patients with diabetes taking tadalafil 20 mg reported improved erections.