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

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ClinicalTrials.gov Identifier: NCT00654017
Recruitment Status : Completed
First Posted : April 7, 2008
Last Update Posted : April 7, 2008
Sponsor:
Information provided by:
Pfizer

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 with erectile dysfunction and severe renal failure who were on hemodialysis.

Condition or disease Intervention/treatment Phase
Erectile Disfunction Hemodialysis Drug: placebo Drug: sildenafil Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : October 2002
Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. response to Partner's Satisfaction Questionnaire (optional) [ Time Frame: Week 10 ]
  3. total Score of Quality of Life and erectile dysfunction questionnaire [ Time Frame: Baseline and Week 10 ]
  4. monitoring of adverse events (AEs) and measurement of sitting blood pressure and heart rate [ Time Frame: Baseline, and Weeks 2, 4, 6, and 10 ]
  5. response to Question 1 of the Global Efficacy Assessment Question [ Time Frame: Week 10 ]
  6. responses to questions of the IIEF [ Time Frame: Baseline and Week 10 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00654017     History of Changes
Other Study ID Numbers: A1481076
First Posted: April 7, 2008    Key Record Dates
Last Update Posted: April 7, 2008
Last Verified: April 2008

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents