Back to resultsA Study Evaluating the Efficacy and Safety of Sildenafil in Patients With Erectile Dysfunction Receiving Hemodialysis
Primary Purpose
Erectile Disfunction, Hemodialysis
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
placebo
sildenafil
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Disfunction
Eligibility 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.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
placebo
sildenafil
Arm Description
Outcomes
Primary Outcome Measures
Response to questions 3 (frequency of penetration) and 4 (frequency of maintained erection) of the International Index of Erectile Function (IIEF).
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)
response to Partner's Satisfaction Questionnaire (optional)
total Score of Quality of Life and erectile dysfunction questionnaire
monitoring of adverse events (AEs) and measurement of sitting blood pressure and heart rate
response to Question 1 of the Global Efficacy Assessment Question
responses to questions of the IIEF
Full Information
NCT ID
NCT00654017
First Posted
March 31, 2008
Last Updated
January 28, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00654017
Brief Title
A Study Evaluating the Efficacy and Safety of Sildenafil in Patients With Erectile Dysfunction Receiving Hemodialysis
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 Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Disfunction, Hemodialysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Title
sildenafil
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo comparator to be given per protocol.
Intervention Type
Drug
Intervention Name(s)
sildenafil
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
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
Title
response to Partner's Satisfaction Questionnaire (optional)
Time Frame
Week 10
Title
total Score of Quality of Life and erectile dysfunction questionnaire
Time Frame
Baseline and Week 10
Title
monitoring of adverse events (AEs) and measurement of sitting blood pressure and heart rate
Time Frame
Baseline, and Weeks 2, 4, 6, and 10
Title
response to Question 1 of the Global Efficacy Assessment Question
Time Frame
Week 10
Title
responses to questions of the IIEF
Time Frame
Baseline and Week 10
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Fortaleza
State/Province
CE
ZIP/Postal Code
60430-370
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30150-260
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Belo Horizonte
State/Province
Minas Gerais
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Londrina
State/Province
PR
ZIP/Postal Code
86010-010
Country
Brazil
Facility Name
Pfizer Investigational Site
City
JAU
State/Province
SAO Paulo
ZIP/Postal Code
17210-080
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Sorocaba
State/Province
São Paulo
ZIP/Postal Code
18030-205
Country
Brazil
Facility Name
Pfizer Investigational Site
City
São José do Rio Preto
State/Province
São Paulo
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Sao Paulo
ZIP/Postal Code
01323-001
Country
Brazil
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1481076&StudyName=A%20Study%20Evaluating%20the%20Efficacy%20and%20Safety%20of%20Sildenafil%20for%20the%20Treatment%20of%20Erectile%20Dysfunction%20in%20Male%20Patients%20on%20Hemodialysis.
Description
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Learn more about this trial
A Study Evaluating the Efficacy and Safety of Sildenafil in Patients With Erectile Dysfunction Receiving Hemodialysis
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