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NCT00297544 Clinical Trial

Effect of Sildenafil on Endothelial Function

Impotence Clinical Trial

Official title:
Effect of Sildenafil on Endothelial Function

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00297544
Other study ID # 1777-CTIL
Secondary ID
Status Recruiting
Phase N/A
First received February 27, 2006
Last updated February 27, 2006
Start date October 2005

Study information
Verified date November 2005
Source Rambam Health Care Campus
Contact Giris Jacob, Prof., MD, DSc
Phone 972-4-854-2467
Email g_jacob@rambam.health.gov.il
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial 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

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

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 40 Years to 70 Years
Eligibility Inclusion Criteria:

- age 40-70

- impotence

- with and without hypertension, Hypercholesteremia or DM

Exclusion Criteria:

- CHF: NYHA > II

- Stable angina: CCS > II

- Nitrate treatment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

Intervention

Drug:
• Viagra

Locations
Country Name City State
Israel Rambam Medical Center, Recanati Autonomic Dysfunction CTR Haifa

Sponsors (2)
Lead Sponsor Collaborator
Rambam Health Care Campus Pfizer

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Improvement of endothelial function following Viagra treatment, according to platismographia.
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