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. |
ClinicalTrials.gov Identifier: NCT00654017 |
Recruitment Status
:
Completed
First Posted
: April 7, 2008
Last Update Posted
: April 7, 2008
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Erectile Disfunction Hemodialysis | Drug: placebo Drug: sildenafil | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 Start Date : | October 2002 |
Actual Study Completion Date : | April 2005 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: placebo |
Drug: placebo
Placebo comparator to be given per protocol.
|
Active Comparator: sildenafil |
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
|
- 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 ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 19 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00654017
Brazil | |
Pfizer Investigational Site | |
Fortaleza, CE, Brazil, 60430-370 | |
Pfizer Investigational Site | |
Belo Horizonte, MG, Brazil, 30150-260 | |
Pfizer Investigational Site | |
Belo Horizonte, Minas Gerais, Brazil | |
Pfizer Investigational Site | |
Londrina, PR, Brazil, 86010-010 | |
Pfizer Investigational Site | |
JAU, Sao Paulo, Brazil, 17210-080 | |
Pfizer Investigational Site | |
Sorocaba, São Paulo, Brazil, 18030-205 | |
Pfizer Investigational Site | |
São José do Rio Preto, São Paulo, Brazil | |
Pfizer Investigational Site | |
Sao Paulo, Brazil, 01323-001 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
ClinicalTrials.gov Identifier: | NCT00654017 History of Changes |
Other Study ID Numbers: |
A1481076 |
First Posted: | April 7, 2008 Key Record Dates |
Last Update Posted: | April 7, 2008 |
Last Verified: | April 2008 |
Additional relevant MeSH terms:
Erectile Dysfunction Sexual Dysfunction, Physiological Genital Diseases, Male Sexual Dysfunctions, Psychological Mental Disorders Sildenafil Citrate |
Vasodilator Agents Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Urological Agents |