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

Sponsor
Lawson Health Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT00199563
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
40
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
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 :
Aug 1, 2004
Actual Primary Completion Date :
Oct 1, 2007
Actual Study Completion Date :
Dec 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: active drug

Viagra 100 mg / daily for 12 weeks.

Drug: Viagra
Sildenafil 100mg daily for 12 weeks
Other Names:
  • Sildenafil

    		•
    Placebo Comparator: Placebo

    placebo/daily for 12 weeks

    Drug: Viagra
    Sildenafil 100mg daily for 12 weeks
    Other Names:
  • Sildenafil

    		•

    Outcome Measures

    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. [12 weeks]

    Secondary Outcome Measures

    1. IIEF Questionnaire & diary response;Blood pressure and microalbuminuria; Side effects [12 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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 <21ยท

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St. Joseph's Health Care London/Urology Clinic London Ontario Canada N6A 4V2

    Sponsors and Collaborators

    • Lawson Health Research Institute

    Investigators

    • Principal Investigator: Gerald B Brock, MD, Lawson Health Research Institute/St. Joseph's Health Care London

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lawson Health Research Institute
    ClinicalTrials.gov Identifier:
    NCT00199563
    Other Study ID Numbers:
    • R-04-402
    • Ethics Review: 10331
    • R-04-402
    First Posted:
    Sep 20, 2005
    Last Update Posted:
    Nov 6, 2018
    Last Verified:
    Nov 1, 2018
    Keywords provided by Lawson Health Research Institute
    Viagra
    sildenafil
    Additional relevant MeSH terms:
    Erectile Dysfunction
    Sildenafil Citrate

    Study Results

    No Results Posted as of Nov 6, 2018