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Completed

NCT Number: NCT00654017

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

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Key information

Conditions

Erectile Disfunction Hemodialysis

Age range

19 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Fortaleza, Ceará, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

Placebo comparator to be given per protocol.

Sildenafil

Drug

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 outcomes

  1. 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 outcomes

  1. 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

  2. response to Partner's Satisfaction Questionnaire (optional)

    Time frame: Week 10

  3. total Score of Quality of Life and erectile dysfunction questionnaire

    Time frame: Baseline and Week 10

  4. monitoring of adverse events (AEs) and measurement of sitting blood pressure and heart rate

    Time frame: Baseline, and Weeks 2, 4, 6, and 10

  5. response to Question 1 of the Global Efficacy Assessment Question

    Time frame: Week 10

  6. responses to questions of the IIEF

    Time frame: Baseline and Week 10

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2002
Study completion
2005
First posted
Apr 7, 2008
Registry last updated
Feb 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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