Efficacy and Safety of Tadalafil in Hemodialysis Patients | NCT00334477

Studies
Efficacy and Safety of Tadalafil in Hemodialysis Patients

NCT00334477

Sponsor

University of Pernambuco

Status

Unknown status

Last Update Posted

Jun 7, 2006Estimated

Enrollment

Phase

Phase 2

Conditions

Erectile Dysfunction

Interventions

tadalafil

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 6, 2006

First Submission Date that Met QC Criteria

Jun 6, 2006

First Posted Date

Jun 7, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 6, 2006

Last Update Posted Date

Jun 7, 2006Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
tadalafil	Drug

Measure	Description	Time Frame
IIEF 5

Measure	Description	Time Frame
adverse effects reported

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
bruno sp carvalho, md	Contact	558199757974		brunocarvalho@medscape.com

Overall Officials

Name	Affiliation	Role
bruno sp carvalho, md	University of Pernambuco	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de Aeronautica de Recife		Recife	Pernambuco	50000-000	Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16422959	Background	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.
16422874	Background	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.

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D012735	Sexual Dysfunction, Physiological

ID	Term
D002243	Carbolines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds