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Effect of Sildenafil on Endothelial Function

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2005 by Rambam Health Care Campus.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT00297544
First received: February 27, 2006
Last updated: NA
Last verified: November 2005
History: No changes posted
  Purpose

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


Condition Intervention
Impotence
 Drug: Viagra

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Educational/Counseling/Training
Official Title: Effect of Sildenafil on Endothelial Function

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Improvement of endothelial function following Viagra treatment, according to platismographia.

Estimated Enrollment: 60
Study Start Date: October 2005
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00297544

Contacts
Contact: Giris Jacob, Prof., MD, DSc 972-4-854-2467 g_jacob@rambam.health.gov.il
Contact: Yuram Vardi, Prof. , MD 972-4-854-2819 y_vardi@rambam.health.gov.il

Locations
Israel
Rambam Medical Center, Recanati Autonomic Dysfunction CTR Recruiting
Haifa, Israel, 31096
Contact: Giris Jacob, MD, DSc     972-4-854-2594     g_Jacob@rambam.health.gov.il    
Principal Investigator: Yuram Vardi, MD            
Sponsors and Collaborators
Rambam Health Care Campus
Pfizer
Investigators
Principal Investigator: Giris Jacob, Prof, MD, DSc Rambam Health Care Campus
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00297544     History of Changes
Other Study ID Numbers: 1777-CTIL
Study First Received: February 27, 2006
Last Updated: February 27, 2006
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rambam Health Care Campus:
impotence
endothelial function
autonomic nervous system

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Sildenafil
Vasodilator Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013