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

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: NCT00199563
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : November 6, 2018
Information provided by (Responsible Party):
Lawson Health Research Institute

Brief Summary:
  • 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)

Condition or disease Intervention/treatment Phase
Impotence Drug: Viagra Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: The Use and Efficacy of Sildenafil in Diabetic Men With Erectile Dysfunction: the Impact on Endothelial Function, a Pilot Feasibility Study
Study Start Date : August 2004
Actual Primary Completion Date : October 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: active drug
Viagra 100 mg / daily for 12 weeks.
Drug: Viagra
Sildenafil 100mg daily for 12 weeks
Other Name: Sildenafil

Placebo Comparator: Placebo
placebo/daily for 12 weeks
Drug: Viagra
Sildenafil 100mg daily for 12 weeks
Other Name: Sildenafil

Primary Outcome Measures :
  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 Outcome Measures :
  1. IIEF Questionnaire & diary response;Blood pressure and microalbuminuria; Side effects [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00199563

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Canada, Ontario
St. Joseph's Health Care London/Urology Clinic
London, Ontario, Canada, N6A 4V2
Sponsors and Collaborators
Lawson Health Research Institute
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Principal Investigator: Gerald B Brock, MD Lawson Health Research Institute/St. Joseph's Health Care London
Publications of Results:
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Responsible Party: Lawson Health Research Institute Identifier: NCT00199563    
Other Study ID Numbers: R-04-402
Ethics Review: 10331
R-04-402 ( Other Identifier: Lawson Research Institute )
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Keywords provided by Lawson Health Research Institute:
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents