Use of Sildenafil (Viagra) in Diabetic Men With Erectile Dysfunction: the Impact on Blood Vessels
NCT ID: NCT00199563
Last Updated: 2018-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
24 participants
INTERVENTIONAL
2004-08-31
2007-12-31
Brief Summary
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* 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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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active drug
Viagra 100 mg / daily for 12 weeks.
Viagra
Sildenafil 100mg daily for 12 weeks
Placebo
placebo/daily for 12 weeks
Viagra
Sildenafil 100mg daily for 12 weeks
Interventions
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Viagra
Sildenafil 100mg daily for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
Yes
Sponsors
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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Responsible Party
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Principal Investigators
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Gerald B Brock, MD
Role: PRINCIPAL_INVESTIGATOR
Lawson Health Research Institute/St. Joseph's Health Care London
Locations
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St. Joseph's Health Care London/Urology Clinic
London, Ontario, Canada
Countries
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References
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Yu HI, Sheu WH, Lai CJ, Lee WJ, Chen YT. Endothelial dysfunction in type 2 diabetes mellitus subjects with peripheral artery disease. Int J Cardiol. 2001 Mar;78(1):19-25. doi: 10.1016/s0167-5273(00)00423-x.
De Angelis L, Marfella MA, Siniscalchi M, Marino L, Nappo F, Giugliano F, De Lucia D, Giugliano D. Erectile and endothelial dysfunction in Type II diabetes: a possible link. Diabetologia. 2001 Sep;44(9):1155-60. doi: 10.1007/s001250100616.
Feldt-Rasmussen B. Microalbuminuria, endothelial dysfunction and cardiovascular risk. Diabetes Metab. 2000 Jul;26 Suppl 4:64-6.
Desouza C, Parulkar A, Lumpkin D, Akers D, Fonseca VA. Acute and prolonged effects of sildenafil on brachial artery flow-mediated dilatation in type 2 diabetes. Diabetes Care. 2002 Aug;25(8):1336-9. doi: 10.2337/diacare.25.8.1336.
Dishy V, Sofowora G, Harris PA, Kandcer M, Zhan F, Wood AJ, Stein CM. The effect of sildenafil on nitric oxide-mediated vasodilation in healthy men. Clin Pharmacol Ther. 2001 Sep;70(3):270-9. doi: 10.1067/mcp.2001.117995.
Katz SD, Balidemaj K, Homma S, Wu H, Wang J, Maybaum S. Acute type 5 phosphodiesterase inhibition with sildenafil enhances flow-mediated vasodilation in patients with chronic heart failure. J Am Coll Cardiol. 2000 Sep;36(3):845-51. doi: 10.1016/s0735-1097(00)00790-7.
Other Identifiers
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Ethics Review: 10331
Identifier Type: -
Identifier Source: secondary_id
R-04-402
Identifier Type: OTHER
Identifier Source: secondary_id
R-04-402
Identifier Type: -
Identifier Source: org_study_id
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