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Efficacy and Safety of Tadalafil in Hemodialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00334477
Recruitment Status : Unknown
Verified April 2006 by University of Pernambuco.
Recruitment status was:  Not yet recruiting
First Posted : June 7, 2006
Last Update Posted : June 7, 2006
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Drug: tadalafil Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Tadalafil 20mg for the Treatment of Erectile Dysfunction in Chronic Renal Patients in Hemodialysis.

Resource links provided by the National Library of Medicine

Drug Information available for: Tadalafil

Primary Outcome Measures :
  1. IIEF 5

Secondary Outcome Measures :
  1. adverse effects reported

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00334477

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Contact: bruno sp carvalho, md 558199757974

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Hospital de Aeronautica de Recife
Recife, Pernambuco, Brazil, 50000-000
Contact: adriano a calado, phd    558196093629      
Principal Investigator: bruno sp carvalho, md         
Sponsors and Collaborators
University of Pernambuco
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Principal Investigator: bruno sp carvalho, md University of Pernambuco
Additional Information:
Layout table for additonal information Identifier: NCT00334477    
Other Study ID Numbers: acbc01
First Posted: June 7, 2006    Key Record Dates
Last Update Posted: June 7, 2006
Last Verified: April 2006
Keywords provided by University of Pernambuco:
erectile dysfunction
chronic renal dysfunction
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents