Status:
COMPLETED
A Study Evaluating the Efficacy and Safety of Sildenafil in Patients With Erectile Dysfunction Receiving Hemodialysis
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Erectile Disfunction
Hemodialysis
Eligibility:
MALE
19+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2005
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00654017
Start Date
October 1 2002
End Date
April 1 2005
Last Update
February 1 2021
Active Locations (8)
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1
Pfizer Investigational Site
Fortaleza, Ceará, Brazil, 60430-370
2
Pfizer Investigational Site
Belo Horizonte, Minas Gerais, Brazil, 30150-260
3
Pfizer Investigational Site
Belo Horizonte, Minas Gerais, Brazil
4
Pfizer Investigational Site
Londrina, Paraná, Brazil, 86010-010