Clinical trial NCT00654017: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Erectile Disfunction
Hemodialysis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-07
Enrollment: 100
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Response to questions 3 (frequency of penetration) and 4 (frequency of maintained erection) of the International Index of Erectile Function (IIEF).
timeFrame: Baseline and Week 10
Secondary outcomes:
measure: rate of successful sexual intercourse (number of attempts at sexual intercourse, number of successful attempts and percentage of attempts that were successful)
timeFrame: Baseline to Week 10
measure: response to Partner's Satisfaction Questionnaire (optional)
timeFrame: Week 10
measure: total Score of Quality of Life and erectile dysfunction questionnaire
timeFrame: Baseline and Week 10
measure: monitoring of adverse events (AEs) and measurement of sitting blood pressure and heart rate
timeFrame: Baseline, and Weeks 2, 4, 6, and 10
measure: response to Question 1 of the Global Efficacy Assessment Question
timeFrame: Week 10
measure: responses to questions of the IIEF
timeFrame: Baseline and Week 10
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Pfizer Investigational Site
state: CE
city: Belo Horizonte
country: Brazil
facility: Pfizer Investigational Site
state: MG
city: Belo Horizonte
country: Brazil
facility: Pfizer Investigational Site
state: Minas Gerais
city: Londrina
country: Brazil
facility: Pfizer Investigational Site
state: PR
city: JAU
country: Brazil
facility: Pfizer Investigational Site
state: SAO Paulo
city: Sorocaba
country: Brazil
facility: Pfizer Investigational Site
state: São Paulo
city: São José do Rio Preto
country: Brazil
facility: Pfizer Investigational Site
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: