Sponsor study identifier
interventional
80
1 country
1
Study Start
May 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Obesity is a public health problem, not only for its high prevalence, but also because of the comorbidities found in it. Within the physiopathological mechanisms associated with obesity is a low-grade inflammatory state that is associated with endothelial dysfunction Endothelial dysfunction is known to be the beginning of the atherosclerotic process that eventually leads to the development of cardiovascular disease. Erectile dysfunction is an example of endothelial dysfunction, where blood flow is compromised as a consequence of a reduction in the production of nitric oxide among others. Tadalafil, which is an inhibitor of PDE-5, is currently used as a treatment for erectile dysfunction. However, it has been observed that the administration of tadalafil in patients with éndothelial dysfunction decreases arterial stiffness, having a positive effect on it, in addition it reduces the pulse pressure, systolic and diastolic pressure.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 19, 2019
Actual (reported)April 5, 2019
Actual (reported)May 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
vasodilatation mediated by flow
the effect of administration of tadalafil on vasodilatation mediated by flow with UNEXEF in patients with obesity grade I-II and erectil dysfunction. A double-blind clinical trial with randomization and control group will be carried out.
24 hours
International Index Erectile Function
24 hours
Male patients aged 25-60 years, BMI ≥30, without comorbidities will be included. They should not be under treatment with iPDE5 or statins, nor should they have uncontrolled ischemic heart disease. To carry out this test, two groups will be created: the first will receive a single dose of tadalafil 20 mg orally
Male patients aged 25-60 years, BMI ≥30, without comorbidities will be included. They should not be under treatment with iPDE5 or statins, nor should they have uncontrolled ischemic heart disease. To carry out this test, two groups will be created: the second will receive 20 mg of calcined magnesia (placebo),after a single administration
tadalafil 20 mg orally ,after a single administration
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Fernando Grover Paez
Guadalajara, Jalisco, 44340, Mexico
First Submitted
February 19, 2019
First Posted
April 5, 2019
Study Start
May 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Primary Completion
September 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 5, 2019
Record last verified: 2019-04
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Source: ClinicalTrials.gov.
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