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

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Fortaleza, CE, 60430-370 Brazil
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Erectile Disfunction, Hemodialysis
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
19+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 an erection sufficient for a satisfactory sexual performance".

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00654017
Pfizer
Completed
A Study Evaluating the Efficacy and Safety of Sildenafil in Patients With Erectile Dysfunction Receiving Hemodialysis

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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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Erectile Disfunction
  • Hemodialysis
  • Drug: placebo
    Placebo comparator to be given per protocol.
  • 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
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
  • Active Comparator: sildenafil
    Intervention: Drug: sildenafil
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
April 2005
Not Provided

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.
Sexes Eligible for Study: Male
19 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT00654017
A1481076
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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