ImpotenceNCT00297544
Effect of Sildenafil on Endothelial Function
A study testing Viagra in people with Impotence, run by Rambam Health Care Campus at 1 site in Israel.
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 Read more about this study
- Who is it for?
- Ages 40 to 70 years, men only
- Conditions the study is for
- Impotence
- What is being tested?
- Viagra
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2005to not given
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 40-70
- impotence
- with and without hypertension, Hypercholesteremia or DM
Who cannot join
- CHF: NYHA > II
- Stable angina: CCS > II
- Nitrate treatment
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rambam Medical Center, Recanati Autonomic Dysfunction CTR
Haifa, 31096
Giris Jacob, MD, DSc, 972-4-854-2594, g_Jacob@rambam.health.gov.il
Yuram Vardi, MD
About this study
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
Read the 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
- Conditions
- Impotence
- Being tested
- Viagra
- Keywords
- impotence, endothelial function, autonomic nervous system
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ViagraDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of endothelial function following Viagra treatment, according to platismographia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2006 (estimated)
- Study startOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ImpotenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Giris Jacob, Prof, MD, DSc, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00297544
- Sponsor's protocol ID
- 1777-CTIL
- Status last verified
- Nov 2005
- First submitted
- 27 Feb 2006
- Last updated
- 28 Feb 2006
- Results posted
- No
Publications
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.
PubMed 15758774Vardi 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.
PubMed 19837434