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A Study Evaluating the Efficacy and Safety of Sildenafil in Patients With Erectile Dysfunction Receiving Hemodialysis | Clinical Trials | Clareo Health

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

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

NCT00654017•Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

19 - No limit years

Sex

MALE

Healthy Volunteers

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.

Locations (8)

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

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

Key Dates

Start Date

October 1, 2002

Completion Date

April 1, 2005

Last Updated

February 1, 2021

Enrollment

100

ESTIMATED participants

Conditions

Erectile DisfunctionHemodialysis

Interventions

placebo

DRUG

sildenafil

DRUG

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 1, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

TRIal of STatin Therapy Effect on Androgen Status and Erectile functioN in Men

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