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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gerald Brock, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00199563
First received: September 13, 2005
Last updated: January 24, 2013
Last verified: September 2005
  Purpose
  • 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 Intervention Phase
Impotence
Drug: Viagra
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: The Use and Efficacy of Sildenafil in Diabetic Men With Erectile Dysfunction: the Impact on Endothelial Function, a Pilot Feasibility Study

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • IIEF Questionnaire & diary response;Blood pressure and microalbuminuria; Side effects [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: August 2004
Study Completion Date: December 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00199563

Locations
Canada, Ontario
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
  More Information

Publications:
Responsible Party: Gerald Brock, Professor, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00199563     History of Changes
Other Study ID Numbers: R-04-402, Ethics Review: 10331, R-04-402
Study First Received: September 13, 2005
Last Updated: January 24, 2013
Health Authority: Canada: Health Canada

Keywords provided by Lawson Health Research Institute:
Viagra
sildenafil

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Sildenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents

ClinicalTrials.gov processed this record on August 28, 2014