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Effect of Sildenafil on Endothelial Function

Primary Purpose

Impotence

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Viagra

About this trial

This is an interventional educational/counseling/training trial for Impotence focused on measuring impotence, endothelial function, autonomic nervous system

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: age 40-70 impotence with and without hypertension, Hypercholesteremia or DM Exclusion Criteria: CHF: NYHA > II Stable angina: CCS > II Nitrate treatment

Sites / Locations

Rambam Medical Center, Recanati Autonomic Dysfunction CTRRecruiting

Outcomes

Primary Outcome Measures

Improvement of endothelial function following Viagra treatment, according to platismographia.

Secondary Outcome Measures

Full Information

NCT ID

NCT00297544

First Posted

February 27, 2006

Last Updated

February 27, 2006

Sponsor

Rambam Health Care Campus

Collaborators

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00297544

Brief Title

Effect of Sildenafil on Endothelial Function

Official Title

Effect of Sildenafil on Endothelial Function

Study Type

Interventional

2. Study Status

Record Verification Date

November 2005

Overall Recruitment Status

Unknown status

Study Start Date

October 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Rambam Health Care Campus

Collaborators

Pfizer

4. Oversight

5. Study Description

Brief Summary

We are investigating the chronic effect of daily assumption of Viagra on the blood vessels function in patients with impotence. The study will include 2 groups: 1- patients with multiple risk factors, e.g. hypertension 2- patients with no cardiovascular risk factors

Detailed Description

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Impotence

Keywords

impotence, endothelial function, autonomic nervous system

7. Study Design

Primary Purpose

Educational/Counseling/Training

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

60 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Viagra

Primary Outcome Measure Information:

Title

Improvement of endothelial function following Viagra treatment, according to platismographia.

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: age 40-70 impotence with and without hypertension, Hypercholesteremia or DM Exclusion Criteria: CHF: NYHA > II Stable angina: CCS > II Nitrate treatment

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Giris Jacob, Prof., MD, DSc

Phone

972-4-854-2467

g_jacob@rambam.health.gov.il

First Name & Middle Initial & Last Name or Official Title & Degree

Yuram Vardi, Prof., MD

Phone

972-4-854-2819

y_vardi@rambam.health.gov.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Giris Jacob, Prof, MD, DSc

Organizational Affiliation

Rambam Health Care Campus

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rambam Medical Center, Recanati Autonomic Dysfunction CTR

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Giris Jacob, MD, DSc

Phone

972-4-854-2594

g_Jacob@rambam.health.gov.il

First Name & Middle Initial & Last Name & Degree

Yuram Vardi, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

15758774

Citation

Dayan L, Greunwald I, Vardi Y, Jacob G. A new clinical method for the assessment of penile endothelial function using the flow mediated dilation with plethysmography technique. J Urol. 2005 Apr;173(4):1268-72. doi: 10.1097/01.ju.0000152290.71948.bf.

Results Reference

background

PubMed Identifier

19837434

Citation

Vardi Y, Appel B, Ofer Y, Greunwald I, Dayan L, Jacob G. Effect of chronic sildenafil treatment on penile endothelial function: a randomized, double-blind, placebo controlled study. J Urol. 2009 Dec;182(6):2850-5. doi: 10.1016/j.juro.2009.08.025. Epub 2009 Oct 17.

Results Reference

derived

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Effect of Sildenafil on Endothelial Function

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