Efficacy and Safety of Tadalafil in Hemodialysis Patients

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2006 by University of Pernambuco.
Recruitment status was Not yet recruiting

Sponsor:

Information provided by:

University of Pernambuco

ClinicalTrials.gov Identifier:

NCT00334477

First received: June 6, 2006

Last updated: NA

Last verified: April 2006

History: No changes posted

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 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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 NLM:

MedlinePlus related topics: Dialysis Erectile Dysfunction

Drug Information available for: Tadalafil

U.S. FDA Resources

Further study details as provided by University of Pernambuco:

Primary Outcome Measures:

IIEF 5

Secondary Outcome Measures:

adverse effects reported

Estimated Enrollment:

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
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

University of Pernambuco

More Information

Additional 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.

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

Keywords provided by University of Pernambuco:

erectile dysfunction
chronic renal dysfunction
tadalafil

Additional relevant MeSH terms:

Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Tadalafil
Phosphodiesterase 5 Inhibitors

Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 16, 2012

To Top