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

Purpose

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.

Condition	Intervention	Phase
Erectile Disfunction Hemodialysis	Drug: placebo Drug: sildenafil	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Dialysis Erectile Dysfunction

Drug Information available for: Sildenafil Sildenafil citrate

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Response to questions 3 (frequency of penetration) and 4 (frequency of maintained erection) of the International Index of Erectile Function (IIEF). [ Time Frame: Baseline and Week 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

rate of successful sexual intercourse (number of attempts at sexual intercourse, number of successful attempts and percentage of attempts that were successful) [ Time Frame: Baseline to Week 10 ] [ Designated as safety issue: No ]
response to Partner's Satisfaction Questionnaire (optional) [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
total Score of Quality of Life and erectile dysfunction questionnaire [ Time Frame: Baseline and Week 10 ] [ Designated as safety issue: No ]
monitoring of adverse events (AEs) and measurement of sitting blood pressure and heart rate [ Time Frame: Baseline, and Weeks 2, 4, 6, and 10 ] [ Designated as safety issue: Yes ]
response to Question 1 of the Global Efficacy Assessment Question [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
responses to questions of the IIEF [ Time Frame: Baseline and Week 10 ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	October 2002
Study Completion Date:	April 2005

Arms	Assigned Interventions
Placebo Comparator: placebo	Drug: placebo Placebo comparator to be given per protocol.
Active Comparator: sildenafil	Drug: 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

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654017

Locations

Brazil
Pfizer Investigational Site
Fortaleza, CE, Brazil, 60430-370
Pfizer Investigational Site
Belo Horizonte, MG, Brazil, 30150-260
Pfizer Investigational Site
Belo Horizonte, Minas Gerais, Brazil
Pfizer Investigational Site
Londrina, PR, Brazil, 86010-010
Pfizer Investigational Site
JAU, Sao Paulo, Brazil, 17210-080
Pfizer Investigational Site
Sorocaba, São Paulo, Brazil, 18030-205
Pfizer Investigational Site
São José do Rio Preto, São Paulo, Brazil
Pfizer Investigational Site
Sao Paulo, Brazil, 01323-001

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00654017 History of Changes
Other Study ID Numbers:	A1481076
Study First Received:	March 31, 2008
Last Updated:	April 2, 2008
Health Authority:	Brazil: Ministry of Health

Additional relevant MeSH terms:

Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Sildenafil
Vasodilator Agents

Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013