A Study Evaluating the Efficacy and Safety of Sildenafil in Patients With Erectile Dysfunction Receiving Hemodialysis

Multicenter, Double-Blind, Randomized, Placebo-controlled Study of Flexible, Titration Dose Administered on an As Needed Basis (PRN) to Evaluate the Efficacy and the Safety of Sildenafil for the Treatment of Erectile Dysfunction in Male Patients on Hemodialysis

The study was done to evaluate the efficacy, safety, and tolerability of orally administered sildenafil taken as needed about one hour before sexual activity after a 10-week period in male outpatients with erectile dysfunction and severe renal failure who were on hemodialysis.

Inclusion Criteria:

• 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 <21 and defined as an "incapacity to obtain and/or maintain an erection sufficient for a satisfactory sexual performance".

Exclusion Criteria:

• 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.