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

Hemodialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00654017
• Other study ID #: A1481076
• Status: Completed
• Phase: Phase 4
• Start date: October 2002
• Est. completion date: April 2005

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Erectile Disfunction
• Erectile Dysfunction
• Hemodialysis

Intervention

Drug:
• placebo
Placebo comparator to be given per protocol.
• sildenafil
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

Locations

Country	Name	City	State
Brazil	Pfizer Investigational Site	Belo Horizonte	MG
Brazil	Pfizer Investigational Site	Belo Horizonte	Minas Gerais
Brazil	Pfizer Investigational Site	Fortaleza	CE
Brazil	Pfizer Investigational Site	JAU	SAO Paulo
Brazil	Pfizer Investigational Site	Londrina	PR
Brazil	Pfizer Investigational Site	São José do Rio Preto	São Paulo
Brazil	Pfizer Investigational Site	Sao Paulo
Brazil	Pfizer Investigational Site	Sorocaba	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	response to Partner's Satisfaction Questionnaire (optional)		Week 10
Secondary	total Score of Quality of Life and erectile dysfunction questionnaire		Baseline and Week 10
Secondary	monitoring of adverse events (AEs) and measurement of sitting blood pressure and heart rate		Baseline, and Weeks 2, 4, 6, and 10
Secondary	response to Question 1 of the Global Efficacy Assessment Question		Week 10
Secondary	responses to questions of the IIEF		Baseline and Week 10

External Links

•   To obtain contact information for a study center near you, click here.