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Efficacy and Safety of Tadalafil in Hemodialysis Patients

Efficacy and Safety of Tadalafil 20mg for the Treatment of Erectile Dysfunction in Chronic Renal Patients in Hemodialysis.

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00334477
Enrollment
60
Registered
2006-06-07
Start date
Unknown
Completion date
Unknown
Last updated
2006-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction

Keywords

erectile dysfunction, chronic renal dysfunction, tadalafil

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.

Interventions

DRUGtadalafil

Sponsors

University of Pernambuco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
IIEF 5

Secondary

MeasureTime frame
adverse effects reported

Countries

Brazil

Contacts

Primary Contactbruno sp carvalho, md
brunocarvalho@medscape.com558199757974

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026