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

Impotence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00199563
• Other study ID #: R-04-402
• Secondary ID: Ethics Review: 1
• Status: Completed
• Phase: Phase 4
• Start date: August 2004
• Est. completion date: December 2007

Study information

• Verified date: November 2018
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction
• Impotence

Intervention

Drug:
• Viagra
Sildenafil 100mg daily for 12 weeks

Locations

Country	Name	City	State
Canada	St. Joseph's Health Care London/Urology Clinic	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	IIEF Questionnaire & diary response;Blood pressure and microalbuminuria; Side effects		12 weeks