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OpenTrials
Completed

NCT Number: NCT00199563

Use of Sildenafil (Viagra) in Diabetic Men With Erectile Dysfunction: the Impact on Blood Vessels

* To evaluate the impact of nightly sildenafil vs placebo use on diabetic men with and without proven endothelial dysfunction and coexisting erectile concerns. * To determine if chronic sildenafil use compared to placebo positively impacts endothelial function among a cohort of diabetic mend with erectile dysfunction * To assess the salvage rate of sildenafil - failures who demonstrate improved response rates over time with chronic use * To assess if microalbuminuria predicts flow-mediated dilation (FMD) response * To measure and identify if other patient specific characteristics predict for sildenafil erectile response and flow-mediated dilatation (FMD) response over time (patient specifics; blood pressure, HBA1c, weight, BMI, age IIEF score at baseline)

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Key information

Conditions

Impotence Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

St. Joseph's Health Care London/Urology Clinic

London, Ontario, N6A 4V2, Canada

About this study

60 type II diabetic men with erectile dysfunction will be enrolled in this trial, evaluated over a 12 week period. Randomization into one of two arms (placebo, daily sildenafil 50mg) will be a doubly blinded. Subjects will be followed by IIEF, diaries and brachial forearm medial dilatation duplex scans, urinary microalbuminuria and serum chemistry.

Study time-points are at baseline, 6 and 12 weeks.

Study participants will be instructed to use the study medication at the specified frequency but will be allowed flexibility to suit their erectile needs.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age > 18 years of age
  • Type 2 diabetes > 6 months in duration. Men using oral hypoglycemic agents and /or insulin will be permitted into the trial.
  • Stable hetero- sexual relationship for > 6 months
  • IIEF score at baseline <21·
  • Agrees to sign informed consent

Exclusion criteria

  • Known hypersensitivity to sildenafil
  • Use of nitrates
  • Use of anti-coagulants
  • History of significant heart disease, +/or myocardial infarction within last 6 months
  • Unable to understand or unwilling to sign informed consent
  • Concomitant use of erectogenic agent during study

Treatment and study plan

Viagra

Drug

Sildenafil 100mg daily for 12 weeks

Other names: Sildenafil

Primary outcomes

  1. Determine if PDE5 use over 12 week period in ED diabetic men improves endothelial function as measured by FMD of the brachial artery, as compared to placebo; Assess treatment response to sildenafil over a 12 week period of exposure compared to placebo.

    Time frame: 12 weeks

Secondary outcomes

  1. IIEF Questionnaire & diary response;Blood pressure and microalbuminuria; Side effects

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Official study title

The Use and Efficacy of Sildenafil in Diabetic Men With Erectile Dysfunction: the Impact on Endothelial Function, a Pilot Feasibility Study

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Sep 20, 2005
Registry last updated
Nov 6, 2018

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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