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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Placebo comparator to be given per protocol.
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
Pfizer Investigational Site
Fortaleza, Ceará, Brazil
Pfizer Investigational Site
Belo Horizonte, Minas Gerais, Brazil
Pfizer Investigational Site
Belo Horizonte, Minas Gerais, Brazil
Pfizer Investigational Site
Londrina, Paraná, Brazil
Response to questions 3 (frequency of penetration) and 4 (frequency of maintained erection) of the International Index of Erectile Function (IIEF).
Time frame: Baseline and Week 10
rate of successful sexual intercourse (number of attempts at sexual intercourse, number of successful attempts and percentage of attempts that were successful)
Time frame: Baseline to Week 10
response to Partner's Satisfaction Questionnaire (optional)
Time frame: Week 10
total Score of Quality of Life and erectile dysfunction questionnaire
Time frame: Baseline and Week 10
monitoring of adverse events (AEs) and measurement of sitting blood pressure and heart rate
Time frame: Baseline, and Weeks 2, 4, 6, and 10
response to Question 1 of the Global Efficacy Assessment Question
Time frame: Week 10
responses to questions of the IIEF
Time frame: Baseline and Week 10
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Pfizer Investigational Site
Jaú, São Paulo, Brazil
Pfizer Investigational Site
São José do Rio Preto, São Paulo, Brazil
Pfizer Investigational Site
Sorocaba, São Paulo, Brazil
Pfizer Investigational Site
São Paulo, Brazil