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

November 2, 2018 updated by: Lawson Health Research Institute

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

  • 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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 4V2
        • St. Joseph's Health Care London/Urology Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
IIEF Questionnaire & diary response;Blood pressure and microalbuminuria; Side effects
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Actual)

November 6, 2018

Last Update Submitted That Met QC Criteria

November 2, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-04-402 (Other Identifier: Lawson Research Institute)
  • Ethics Review: 10331

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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