Patients had a documented clinical diagnosis of erectile dysfunction, a sexual partner for
the duration of the study, and have a HbAlc of less than or equal to 10 at screening. Type
2 diabetic patients currently on insulin or on combination therapy with an oral
hypoglycemic agent were not excluded.
Excluded were subjects who had taken more than 6 doses of any PDE5 inhibitor and/or had
taken their last dose less than 4 weeks prior to the screening visit; subjects with resting
sitting and/or standing hypotension (BP 170/110mmHg);
and subjects with significant cardiovascular disease, including cardiac failure, myocardial
infarction, unstable angina, stroke or transient ischemic attack (TIA), symptomatic or
clinically significant cardiac arrhythmias including atrial fibrillation in the last 3
months.