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Efficacy and Safety of Tadalafil in Hemodialysis Patients

U

University of Pernambuco

Status and phase

Unknown
Phase 2

Conditions

Erectile Dysfunction

Treatments

Drug: tadalafil

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

The purpose of this study is to check the safety and efficacy of a pde5 inhibitor, tadalafil, is a special group of patients: Renal chronic patients in hemodialysis treatment.

Full description

In our country, the number of patients in hemodialysis for the treatment of renal chronic dysfunction is very huge. As we know this group has a greater prevalence of sexual dysfunction than the general population, and among these dysfunctions erectile disfunction(ED) occupies maybe the most important position.

With the advent of the increase aging of the nation´s population and the small number of organ donations, the number of men suffering from ED in hemodialysis surely will be very significant causing a very important problem for our health system.

Up to now there´s little indexed publications supporting the use of tadalafil in this special group of men. Another PDE 5 inhibitor, sildenafil, was used in this patients with success and safety but obviously we need other options with the same efficacy.

We intend this study to give us more background to treat ED in this already unfortunate ones.

Sex

Male

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Men between 18 and 70 years old
  • Diagnosticated ED for 6 months at least
  • Accept the protocol
  • Sign the informed consent
  • Renal chronic patients in hemodyalisis

Exclusion criteria

  • History of another PDE5 inhibittor use.
  • C.C.I. grade III (NYHA)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Central trial contact

bruno sp carvalho, md

Data sourced from clinicaltrials.gov

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