- Included patients had been in a stable relationship with a female partner for at least
6 months
- A diagnosis of renal failure, with creatinine clearance ≤10 ml/min; been under
hemodialysis for at least 6 months prior to the screening period, and a clinical
diagnosis of erectile dysfunction (ED) as confirmed by International Index of Erectile
Function (IIEF-5) score of
an erection sufficient for a satisfactory sexual performance".
- Patients in regular use of nitrates or nitric oxide donor drugs, or have received a
prescription to use these substances in any formulation
- Patients with genital anatomic malformation that may significantly impair erection
(e.g., serious penile fibrosis)
- Patients with other sexual disorders (e.g., hypoactive sexual desire) considered as a
primary diagnosis, with a coexisting ED diagnosis, including patients receiving
anti-androgenic therapy whose libido has not been preserved; patients receiving
hormonal replacement therapy for at least 6 months, or whose dose has not been
stabilized within the last 6 months before the study screening period
- Patients with diabetes mellitus presenting poor control of their diabetes and/or
proliferate diabetes retinopathy.