ED patient must:
- Be male, 18 years of age with no upper age limit;
- Have a documented clinical diagnosis of erectile dysfunction confirmed by an Erectile
Function (IIEF) score 25. Erectile dysfunction is defined as "the inability to
achieve and/or maintain an erection of the penis sufficient to permit satisfactory
sexual performance" (Impotence-NIH Consensus Conference, JAMA 1993, 270: 83-90);
- Have a stable female partner for at least 6 months prior to screening.
- Have a known hypersensitivity to sildenafil or any component of the study medication;
medical history of treatment-related intolerable side effects to sildenafil
- Be currently prescribed, taking and/or likely to be treated with nitrates or nitric
oxide donors in any form on either a regular or intermittent basis.