Use of Sildenafil (Viagra) in Diabetic Men With Erectile Dysfunction: the Impact on Blood Vessels
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|ClinicalTrials.gov Identifier: NCT00199563|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : January 25, 2013
- 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 or disease||Intervention/treatment||Phase|
|Impotence||Drug: Viagra||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Use and Efficacy of Sildenafil in Diabetic Men With Erectile Dysfunction: the Impact on Endothelial Function, a Pilot Feasibility Study|
|Study Start Date :||August 2004|
|Actual Primary Completion Date :||October 2007|
|Actual Study Completion Date :||December 2007|
Active Comparator: active drug
Viagra 100 mg / daily for 12 weeks.
Sildenafil 100mg daily for 12 weeks
Other Name: Sildenafil
Placebo Comparator: Placebo
placebo/daily for 12 weeks
- 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 ]
- IIEF Questionnaire & diary response;Blood pressure and microalbuminuria; Side effects [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00199563
|St. Joseph's Health Care London/Urology Clinic|
|London, Ontario, Canada, N6A 4V2|
|Principal Investigator:||Gerald B Brock, MD||Lawson Health Research Institute/St. Joseph's Health Care London|