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 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT02029560
Eligibility Criteria:
Inclusion Criteria:
Patients who have been diagnosed with BPH by digital rectal exam or ultrasonographic findings and meet the following criteria.
1. Male, 50 years or older
2. Patients with a total I-PSS score ≥ 8
3. Patients with a QoL score ≥ 3
4. Patients who voluntarily decided to participate and have filled out consent form
Exclusion Criteria:
1. Patients with an allergy to α-blockers
2. Patients with history of severe arrhythmia, cardiac failure, cardiac infarction, unstable angina, cerebral infarction within 6 months
3. Patients with severe hepatic disorders (hepatic insufficiency, cirrhosis, jaundice, hepatoma)
4. Patients with renal dysfunction
5. Has PSA value ≥ 10ng/ml or has been diagnosed with tumor by biopsy even if PSA value is lower than 10ng/ml,
6. Patients with history of prostate surgery
7. Patients previously administered with 5α-reductase inhibitor within 3 months
8. Patients previously administered with α1-adrenoceptor antagonist within 1 month
9. Patients who are taking the following drugs at the start of study or those who have to take during the 12 weeks of the study: αβ-adrenoceptor antagonist, α-adrenoceptor agonist, anticholinergic (tolterodine, oxybutynin, etc.)
10. Patients with a history of intrapelvic radiation therapy or prostatic hyperthermia
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
50 Years
Study:
NCT02029560
Study Brief:
Protocol Section:
NCT02029560