Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT00593593
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
MALE
Study:
NCT00593593
Study Brief:
Protocol Section:
NCT00593593