Efficacy and Safety of Tadalafil in Hemodialysis Patients

NCT00334477 | Unknown Phase 2

• 1 other identifier: acbc01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Erectile Dysfunction

Keywords

erectile dysfunction; chronic renal dysfunction; tadalafil

Outcome Measures

Primary Outcomes (1)

• IIEF 5

Secondary Outcomes (1)

• adverse effects reported

Interventions

tadalafil DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History of another PDE5 inhibittor use.
• C.C.I. grade III (NYHA)

Sponsors & Collaborators

• University of Pernambuco: lead

Study Sites (1)

Hospital de Aeronautica de Recife

Recife, Pernambuco, 50000-000, Brazil

Location

Related Publications (5)

• 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.

  PMID: 16422959 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.

  PMID: 16422874 BACKGROUND

• 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.

  PMID: 16422847 BACKGROUND

• 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.

  PMID: 16354303 BACKGROUND

• 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.

  PMID: 16307689 BACKGROUND

Related Links

• International Society for Sexual Medicine

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• bruno sp carvalho, md

  University of Pernambuco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

bruno sp carvalho, md

CONTACT

558199757974; brunocarvalho@medscape.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 6, 2006
• First Posted: June 7, 2006
• Last Updated: June 7, 2006

Record last verified: 2006-04

Locations

BR (1)