Pharmacovigilance Study To Evaluate Safety Of AVODART In Subjects With Benign Prostate Hyperplasia

A Pharmacovigilance Study to Evaluate Safety of AVODART (Dutasteride) Administration 0,5 mg Once Daily, for 52 Weeks, in Subjects With Benign Prostate Hyperplasia

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00593593

Enrollment

1000

Registered

2008-01-15

Start date

2004-12-31

Completion date

Unknown

Last updated

2008-10-15

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

Conditions

Benign Prostatic Hyperplasia

Keywords

benign prostate hyperplasia, Dutasteride, pharmacovigilance

Brief summary

This study has 4 phases: screening phase (visit 1), treatment phase (visit 2 - 6 mths after treatment initiation), and end of treatment phase (visit 3 - end of year 1). Only in the case a serious adverse event (SAE) arises, will there be a follow up phase (visit 4).

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Healthy volunteers

Inclusion criteria

* Subject should fulfil criteria for the subscription of AVODART as these are mentioned in the SPC * Subject should be diagnosed with benign prostate hyperplasia * Subject's prostate volume should be equal or greater than 30 cm3

Exclusion criteria

* Known hypersensitivity to any of the AVODART compounds * Suffers from a serious illness which either is not properly controlled or as per investigator´s judgment could interfere with the subject´s compliance into the trial * Receives treatment with enzyme inhibitors CYP3A4 and CYP3A5. * History of severe liver failure

Outcome results