Efficacy and Safety of Tadalafil in Hemodialysis Patients
NCT ID: NCT00334477
Last Updated: 2006-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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tadalafil
Eligibility Criteria
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Inclusion Criteria
* Diagnosticated ED for 6 months at least
* Accept the protocol
* Sign the informed consent
* Renal chronic patients in hemodyalisis
Exclusion Criteria
* C.C.I. grade III (NYHA)
18 Years
70 Years
MALE
No
Sponsors
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University of Pernambuco
OTHER
Principal Investigators
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bruno sp carvalho, md
Role: PRINCIPAL_INVESTIGATOR
University of Pernambuco
Locations
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Hospital de Aeronautica de Recife
Recife, Pernambuco, Brazil
Countries
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Central Contacts
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Facility Contacts
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adriano a calado, phd
Role: primary
References
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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. doi: 10.1111/j.1743-6109.04042.x.
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. doi: 10.1111/j.1743-6109.2005.20360.x.
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. doi: 10.1111/j.1743-6109.2005.00068.x.
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. doi: 10.1186/1471-2490-5-18.
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. doi: 10.1185/030079905X65538.
Related Links
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International Society for Sexual Medicine
Other Identifiers
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acbc01
Identifier Type: -
Identifier Source: org_study_id