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

NCT00654017 | Completed Phase 4

• 1 other identifier: A1481076
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 8

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.

Conditions

Erectile Disfunction; Hemodialysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (2)

placebo

PLACEBO COMPARATOR

Drug: placebo

sildenafil

ACTIVE COMPARATOR

Drug: sildenafil

Interventions

placebo DRUG

Placebo comparator to be given per protocol.

placebo

sildenafil DRUG

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

sildenafil

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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".

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (8)

Pfizer Investigational Site

Fortaleza, Ceará, 60430-370, Brazil

Location

Pfizer Investigational Site

Belo Horizonte, Minas Gerais, 30150-260, Brazil

Location

Pfizer Investigational Site

Belo Horizonte, Minas Gerais, Brazil

Location

Pfizer Investigational Site

Londrina, Paraná, 86010-010, Brazil

Location

Pfizer Investigational Site

Jaú, São Paulo, 17210-080, Brazil

Location

Pfizer Investigational Site

São José do Rio Preto, São Paulo, Brazil

Location

Pfizer Investigational Site

Sorocaba, São Paulo, 18030-205, Brazil

Location

Pfizer Investigational Site

São Paulo, 01323-001, Brazil

Location

Related Links

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

MeSH Terms

Interventions

Sildenafil Citrate

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2008
• First Posted: April 7, 2008
• Study Start: October 1, 2002
• Study Completion: April 1, 2005
• Last Updated: February 1, 2021

Record last verified: 2021-01

Locations

BR (8)