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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00654017
Recruitment Status : Completed
First Posted : April 7, 2008
Last Update Posted : April 7, 2008
Information provided by:

March 31, 2008
April 7, 2008
April 7, 2008
October 2002
Not Provided
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 ]
Same as current
No Changes Posted
  • 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 ]
  • response to Partner's Satisfaction Questionnaire (optional) [ Time Frame: Week 10 ]
  • total Score of Quality of Life and erectile dysfunction questionnaire [ Time Frame: Baseline and Week 10 ]
  • monitoring of adverse events (AEs) and measurement of sitting blood pressure and heart rate [ Time Frame: Baseline, and Weeks 2, 4, 6, and 10 ]
  • response to Question 1 of the Global Efficacy Assessment Question [ Time Frame: Week 10 ]
  • responses to questions of the IIEF [ Time Frame: Baseline and Week 10 ]
Same as current
Not Provided
Not Provided
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
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 Identifier (NCT Number) in Medline.
Same as current
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)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Not Provided
Study Director: Pfizer Call Center Pfizer
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP