Erectile Disfunction, Hemodialysis
Conditions
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.
Interventions
DRUGplacebo
Placebo comparator to be given per protocol.
DRUGsildenafil
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
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| response to Partner's Satisfaction Questionnaire (optional) | Week 10 |
| total Score of Quality of Life and erectile dysfunction questionnaire | 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) | Baseline to Week 10 |
| response to Question 1 of the Global Efficacy Assessment Question | Week 10 |
| responses to questions of the IIEF | 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 |
Countries
Brazil
Outcome results
None listed