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

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Fortaleza, CE, 60430-370 Brazil
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Erectile Disfunction, Hemodialysis
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
19 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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 an erection sufficient for a satisfactory sexual performance".

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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.

NCT00654017
Pfizer
Completed
A Study Evaluating the Efficacy and Safety of Sildenafil in Patients With Erectile Dysfunction Receiving Hemodialysis

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