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 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT01736033
Eligibility Criteria:
Inclusion Criteria:
* Male patients aged over 50
* Clinically diagnosed benign prostate hyperplasia(BPH)
* 8 ≤ IPSS ≤ 30
* 4 ml/sec ≤ Q max ≤ 15 ml/sec
* minimum voided volume ≥ 125 ml
* Post voided residual volume ≤ 250
* Volunteer who singed on informed consent documents
Exclusion Criteria:
* Past history of surgical procedure experience related to BPH
* Past history of taking 5-alpha reductase inhibitor(5-ARI) within 6 months before screening, or for more than 12 months regardless of the point of time
* Past history of taking alpha blocker within 2 weeks before screening
* Past history of acute urinary retention within 3 months before screening
* Serum PSA ≥ 10 ng/ml (but, in the case of 4 ng/ml ≤ PSA \< 10 ng/ml, the patients can be included only if prostate cancer is excluded by prostate biopsy)
* Anatomical abnormalities of lower urinary tracts(urethrostenosis, diverticulosis, bladder neck contracture)
* Clinical status that affects voiding other than BPH(neurogenic bladder, Chronic Prostatitis/Chronic Pelvic Pain Syndrome, urinary infection, etc.)
* Unstable and significant medical condition including below
* Unstable angina pectoris, myocardial infarction, cerebrovascular disease within 6 months before screening
* Past history of malignant tumor including skin basal cell carcinoma within 5 years before screening
* Medically uncontrollable diabetes mellitus, peptic ulcer disease
* Severe hepatic diseases
* Past history of renal failure or renal disease (serum creatinine \> 1.4mg/dl)
* Condition expected serious adverse event due to the investigational drug
* Other conditions considered not eligible for the trial upon investigator's judgement
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
50 Years
Study:
NCT01736033
Study Brief:
Protocol Section:
NCT01736033