Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00199563
Status:
COMPLETED
Last Update Posted:
2018-11-06
First Post:
2005-09-13
Brief Title:
Use of Sildenafil Viagra in Diabetic Men With Erectile Dysfunction the Impact on Blood Vessels
Sponsor:
Lawson Health Research Institute
Organization:
Lawson Health Research Institute
Study Overview
Official Title:
The Use and Efficacy of Sildenafil in Diabetic Men With Erectile Dysfunction the Impact on Endothelial Function a Pilot Feasibility Study
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R-04-402 | OTHER | Lawson Research Institute | None |
| Ethics Review 10331 | None | None | None |