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Efficacy and Safety of Tadalafil in Hemodialysis Patients

Primary Purpose

Erectile Dysfunction

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
tadalafil
Sponsored by
University of Pernambuco
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring erectile dysfunction, chronic renal dysfunction, tadalafil

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Hospital de Aeronautica de Recife

Outcomes

Primary Outcome Measures

IIEF 5

Secondary Outcome Measures

adverse effects reported

Full Information

First Posted
June 6, 2006
Last Updated
June 6, 2006
Sponsor
University of Pernambuco
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1. Study Identification

Unique Protocol Identification Number
NCT00334477
Brief Title
Efficacy and Safety of Tadalafil in Hemodialysis Patients
Official Title
Efficacy and Safety of Tadalafil 20mg for the Treatment of Erectile Dysfunction in Chronic Renal Patients in Hemodialysis.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2006
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Pernambuco

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
erectile dysfunction, chronic renal dysfunction, tadalafil

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
tadalafil
Primary Outcome Measure Information:
Title
IIEF 5
Secondary Outcome Measure Information:
Title
adverse effects reported

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
bruno sp carvalho, md
Phone
558199757974
Email
brunocarvalho@medscape.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
bruno sp carvalho, md
Organizational Affiliation
University of Pernambuco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Aeronautica de Recife
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50000-000
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
adriano a calado, phd
Phone
558196093629
First Name & Middle Initial & Last Name & Degree
bruno sp carvalho, md

12. IPD Sharing Statement

Citations:
PubMed Identifier
16422959
Citation
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.
Results Reference
background
PubMed Identifier
16422874
Citation
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.
Results Reference
background
PubMed Identifier
16422847
Citation
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.
Results Reference
background
PubMed Identifier
16354303
Citation
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.
Results Reference
background
PubMed Identifier
16307689
Citation
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.
Results Reference
background
Links:
URL
http://www.issm.info
Description
International Society for Sexual Medicine

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Efficacy and Safety of Tadalafil in Hemodialysis Patients

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