- Documented clinical diagnosis of ED by using IIEF-EF domain with score of ≤ 25.
- Subjects must be in a stable relationship with the same partner for at least 6 months
and willing to attempt sexual intercourse.
- Subjects in whom sexual activity is inadvisable in the opinion of the investigator
such as significant cardiovascular disease in the last 6 months; including cardiac
failure, myocardial infarction, unstable angina, stroke or transient ischemic attack
(TIA), symptomatic or clinically significant cardiac arrhythmias including atrial
fibrillation.
- Subjects who are currently taking or are likely to be treated with nitrates or nitric
oxide donors in any form (oral, sublingual, buccal, transdermal, inhalational or as
aerosols) on either regular or intermittent basis.