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:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT02972268
Eligibility Criteria:
Inclusion Criteria:
* Over 45 years
* Benign Prostate Hyperplasia diagnosed by 20 mL \< TRUS
* Lower urinary tract symptom suggestive of benign prostate hyperplasia, who spontaneously agree to join and sign to the consent form
Exclusion Criteria:
* Subjects who have a history of the lower urinary tract cancer, including prostate cancer and bladder cancer within the past 3 years
* Subjects who have acute urinary retention within 12 weeks before screening
* Subjects who have clinically significant severe cardiovascular disease(unstable angina, myocardial infarction or arrhythmia) within 24 weeks before screening
* Subjects who have hypersensitivity to investigational product
* Subjects who were suspected or confirmed neurogenic bladder, bladder neck structure, bladder diverticulum
* Subjects who have myasthenia gravis, narrow angle glaucoma
* Subjects who have hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
* SBP \> 180 mmHg or DBP \> 100 mmHg
* HbA1c \> 9.0 %
* Subjects who are judged by the investigators to be unsuitable to participate in the clinical trial.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
45 Years
Study:
NCT02972268
Study Brief:
Protocol Section:
NCT02972268