NCT00297544

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 28, 2006

Completed
Last Updated

February 28, 2006

Status Verified

November 1, 2005

First QC Date

February 27, 2006

Last Update Submit

February 27, 2006

Conditions

Impotence

Keywords

impotenceendothelial functionautonomic nervous system

Outcome Measures

Primary Outcomes (1)

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

Interventions

ViagraDRUG

Eligibility Criteria

Age40 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 40-70
  • impotence
  • with and without hypertension, Hypercholesteremia or DM

You may not qualify if:

  • CHF: NYHA \> II
  • Stable angina: CCS \> II
  • Nitrate treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Medical Center, Recanati Autonomic Dysfunction CTR

Haifa, 31096, Israel

RECRUITING

Related Publications (2)

  • 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.

    PMID: 15758774BACKGROUND

  • 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.

    PMID: 19837434DERIVED

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Giris Jacob, Prof, MD, DSc

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Giris Jacob, Prof., MD, DSc

CONTACT

972-4-854-2467g_jacob@rambam.health.gov.il

Yuram Vardi, Prof., MD

CONTACT

972-4-854-2819y_vardi@rambam.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
ECT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 27, 2006

First Posted

February 28, 2006

Study Start

October 1, 2005

Last Updated

February 28, 2006

Record last verified: 2005-11

Locations

IL(1)