Obesity and Erectile Dysfuntion Clinical Trial
Official title:
Acute and Subacute Effect of Tadalafil Administration on Vasodilatation Mediated by Flow in Patients With Obesity Grade I-ii and Erectil Dysfunction
| NCT number | NCT03905018 |
| Other study ID # | TDLF |
| Secondary ID | |
| Status | Recruiting |
| Phase | Phase 3 |
| First received | |
| Last updated | |
| Start date | May 1, 2019 |
| Est. completion date | September 1, 2019 |
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.
| Status | Recruiting |
| Enrollment | 80 |
| Est. completion date | September 1, 2019 |
| Est. primary completion date | September 1, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 25 Years to 60 Years |
| Eligibility |
Inclusion Criteria: - Male patients - Age 25 to 60 years - Obesity grade I-II - .Sign the inform consent form. - Answer the questionary IIFE Exclusion Criteria: . DM 1-2 - Systemic arterial hypertension - Uncontrolled Mixed Dyslipidemia or under Hypolipemiant Treatment with statins. - Active smoking - Precedent of uncontrolled Ischemic cardiopathy. - Use of anti-inflammatory drugs, including Acetylsalicylic acid, antihypertensive, antihyperglucemic, anti-anginal drugs, recent use of antiviral drugs that contains vasoconstrictors. - Hepatic, renal, thyroid, and/or pulmonary decompensated disease. - The precedent of hypersensibility to the phosphodiesterase-5 inhibitors. - Patients that are under treatmen with iPDE |
| Country | Name | City | State |
|---|---|---|---|
| Mexico | Fernando Grover Paez | Guadalajara | Jalisco |
| Lead Sponsor | Collaborator |
|---|---|
| Centro Universitario de Ciencias de la Salud, Mexico |
Mexico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | International Index Erectile Function | evaluate erectile funtion with a test (IIFE) | 24 hours |