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

NCT00199563 | Completed Phase 4

• 2 other identifiers: R-04-402Ethics Review: 10331
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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)

Conditions

Impotence

Keywords

Viagra; sildenafil

Outcome Measures

Primary Outcomes (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 Outcomes (1)

• IIEF Questionnaire & diary response;Blood pressure and microalbuminuria; Side effects

  12 weeks

Study Arms (2)

active drug

ACTIVE COMPARATOR

Viagra 100 mg / daily for 12 weeks.

Drug: Viagra

Placebo

PLACEBO COMPARATOR

placebo/daily for 12 weeks

Drug: Viagra

Interventions

Viagra DRUG

Sildenafil 100mg daily for 12 weeks

Also known as: Sildenafil

Placebo; active drug

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

St. Joseph's Health Care London/Urology Clinic

London, Ontario, N6A 4V2, Canada

Location

Related Publications (6)

• 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.

  PMID: 11259809 RESULT

• 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.

  PMID: 11596671 RESULT

• Feldt-Rasmussen B. Microalbuminuria, endothelial dysfunction and cardiovascular risk. Diabetes Metab. 2000 Jul;26 Suppl 4:64-6.

  PMID: 10922975 RESULT

• 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.

  PMID: 12145231 RESULT

• 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.

  PMID: 11557915 RESULT

• 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.

  PMID: 10987609 RESULT

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Gerald B Brock, MD

  Lawson Health Research Institute/St. Joseph's Health Care London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: August 1, 2004
• Primary Completion: October 1, 2007
• Study Completion: December 1, 2007
• Last Updated: November 6, 2018

Record last verified: 2018-11

Locations

CA (1)