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Efficacy and Safety of Tadalafil in Hemodialysis Patients

Phase 2
Conditions
Erectile Dysfunction
Registration Number
NCT00334477
Lead Sponsor
University of Pernambuco
Brief Summary

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.

Detailed 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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
Male
Target Recruitment
60
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
IIEF 5
Secondary Outcome Measures
NameTimeMethod
adverse effects reported

Trial Locations

Locations (1)

Hospital de Aeronautica de Recife

🇧🇷

Recife, Pernambuco, Brazil

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