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

Phase 4

Completed

• Conditions: Hemodialysis; Erectile Disfunction
• Interventions: Drug: placebo; Drug: sildenafil

• Registration Number: NCT00654017
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-10
• Study Completion: 2005-04
• Study First Submitted: 2008-03-31
• Study First Submitted QC: 2008-04-02
• Study First Posted: 2008-04-07
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	-
sildenafil	sildenafil	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
responses to questions of the IIEF	Baseline and Week 10
response to Partner's Satisfaction Questionnaire (optional)	Week 10
response to Question 1 of the Global Efficacy Assessment Question	Week 10
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
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇷 Sao Paulo, Brazil