Use of Sildenafil (Viagra) in Diabetic Men With Erectile... | NCT00199563

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

NCT00199563

Sponsor

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

Status

Completed

Last Update Posted

Nov 6, 2018Actual

Enrollment

24Actual

Phase

Phase 4

Conditions

Impotence

Interventions

Viagra

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Ethics Review: 10331
R-04-402	Other Identifier	Lawson Research Institute

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2004

Primary Completion Date

Oct 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 2, 2018

Last Update Posted Date

Nov 6, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
active drug	Active Comparator	Viagra 100 mg / daily for 12 weeks.	Drug: Viagra
Placebo	Placebo Comparator	placebo/daily for 12 weeks	Drug: Viagra

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Viagra	Drug	Sildenafil 100mg daily for 12 weeks	Placebo active drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
IIEF Questionnaire & diary response;Blood pressure and microalbuminuria; Side effects		12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gerald B Brock, MD	Lawson Health Research Institute/St. Joseph's Health Care London	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Joseph's Health Care London/Urology Clinic		London	Ontario	N6A 4V2	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11259809	Result	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.
11596671	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.

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D012735	Sexual Dysfunction, Physiological

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D013450	Sulfones
D013457