Efficacy and Safety of Tadalafil in Hemodialysis Patients - Full Text View

Purpose

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	Intervention	Phase
Erectile Dysfunction	Drug: tadalafil	Phase II

MedlinePlus related topics:

Dialysis Erectile Dysfunction Kidney Failure

ChemIDplus related topics:

Tadalafil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Efficacy and Safety of Tadalafil 20mg for the Treatment of Erectile Dysfunction in Chronic Renal Patients in Hemodialysis.

Further study details as provided by University of Pernambuco:

Primary Outcome Measures:

IIEF 5

Secondary Outcome Measures:

adverse effects reported

Estimated Enrollment:

60

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00334477

Contacts


Contact: bruno sp carvalho, md	558199757974	brunocarvalho@medscape.com

Locations


Brazil, Pernambuco
	Hospital de Aeronautica de Recife	Recruiting
	Recife, Pernambuco, Brazil, 50000-000
	Contact: adriano a calado, phd 558196093629
	Principal Investigator: bruno sp carvalho, md

Sponsors and Collaborators

University of Pernambuco

Investigators


Principal Investigator:	bruno sp carvalho, md	Universidade de pernambuco

More Information

International Society for Sexual Medicine This link exits the ClinicalTrials.gov site

Publications:

McMahon C. Efficacy and safety of daily tadalafil in men with erectile dysfunction previously unresponsive to on-demand tadalafil. J Sex Med. 2004 Nov;1(3):292-300.

McMahon C. Comparison of efficacy, safety, and tolerability of on-demand tadalafil and daily dosed tadalafil for the treatment of erectile dysfunction. J Sex Med. 2005 May;2(3):415-25; discussion 425-7.

Lewis RW, Sadovsky R, Eardley I, O'Leary M, Seftel A, Wang WC, Shen W, Walker DJ, Wong DG, Ahuja S. The efficacy of tadalafil in clinical populations. J Sex Med. 2005 Jul;2(4):517-31.

Moore RA, Derry S, McQuay HJ. Indirect comparison of interventions using published randomised trials: systematic review of PDE-5 inhibitors for erectile dysfunction. BMC Urol. 2005 Dec 14;5:18. Review.

Rosen RC, Shabsigh R, Kuritzky L, Wang WC, Sides GD. The efficacy of tadalafil in improving sexual satisfaction and overall satisfaction in men with mild, moderate, and severe erectile dysfunction: a retrospective pooled analysis of data from randomized, placebo-controlled clinical trials. Curr Med Res Opin. 2005 Nov;21(11):1701-9.

Study ID Numbers:	acbc01
First Received:	June 6, 2006
Last Updated:	June 6, 2006
ClinicalTrials.gov Identifier:	NCT00334477
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by University of Pernambuco:

erectile dysfunction

chronic renal dysfunction

tadalafil

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological

Sexual Dysfunction, Physiological

Mental Disorders

Tadalafil

Genital Diseases, Male

Erectile Dysfunction

Additional relevant MeSH terms:

Phosphodiesterase Inhibitors

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Sexual and Gender Disorders

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 14, 2008

Sponsored by:	University of Pernambuco
Information provided by:	University of Pernambuco
ClinicalTrials.gov Identifier:	NCT00334477