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

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.

Study Overview

• Status: Completed
• Conditions: Hemodialysis; Erectile Disfunction
• Intervention / Treatment: Drug: placebo; Drug: sildenafil

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: October 1, 2002
• Study Completion (Actual): April 1, 2005

Study Registration Dates

• First Submitted: March 31, 2008
• First Submitted That Met QC Criteria: April 2, 2008
• First Posted (Estimate): April 7, 2008

Study Record Updates

• Last Update Posted (Actual): February 1, 2021
• Last Update Submitted That Met QC Criteria: January 28, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate
• Other Study ID Numbers: A1481076