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

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Erectile Disfunction, Hemodialysis

Intervention / Treatment
-----------------
* Drug: placebo
* Drug: sildenafil


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br> | Drug: placebo<br>* Placebo comparator to be given per protocol.<br>|
| Active Comparator: sildenafil<br> | Drug: sildenafil<br>* oral sildenafil citrate at an initial dose of 25 mg, which could have been up-titrated to 50 mg at Visit 3 based on the patient's efficacy, safety and tolerability responses; at Visits 4 and 5, the dose could remain the same, be increased to 100 mg, or decreased to 25 mg depending on the safety, efficacy, and tolerability<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to questions 3 (frequency of penetration) and 4 (frequency of maintained erection) of the International Index of Erectile Function (IIEF). |  | Baseline and Week 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of successful sexual intercourse (number of attempts at sexual intercourse, number of successful attempts and percentage of attempts that were successful) |  | Baseline to Week 10 | 
| response to Partner's Satisfaction Questionnaire (optional) |  | Week 10 | 
| total Score of Quality of Life and erectile dysfunction questionnaire |  | Baseline and Week 10 | 
| monitoring of adverse events (AEs) and measurement of sitting blood pressure and heart rate |  | Baseline, and Weeks 2, 4, 6, and 10 | 
| response to Question 1 of the Global Efficacy Assessment Question |  | Week 10 | 
| responses to questions of the IIEF |  | Baseline and Week 10 |