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 @ 3:09 AM
Ignite Modification Date:
2025-12-25 @ 3:09 AM
NCT ID:
NCT00527605
Eligibility Criteria:
Inclusion:
* Clinical diagnosis of BPH
* AUA-SI \>=12 \[American Urological Association Symptom Index\]
* Qmax \> 5ml/sec and \<=15ml/sec and minimum voided volume of \>=125ml
* Prostate volume \>=30cm(3)
Exclusion:
* Post void residual volume \>250ml
* History or evidence of prostate cancer
* Total serum PSA \<1.5ng/ml or \>10.0ng/ml (Prostate specific antigen)
* Previous prostatic surgery or other invasive procedures to treat BPH.
* History of AUR (Acute Urinary Retention) within 3 months
* History of flexible/rigid cystoscopy or other instrumentation of the urethra within 7 days
* Any causes other than BPH, which may in the judgement of the investigator, result in urinary symptoms or changes in flow rate
* History of hepatic impairment or abnormal liver function tests
* Use of any 5a-reductase inhibitors ,any drugs with antiandrogenic properties or other drugs noted for gynaecomastia effects, or could affect prostate volume, within past 6 months and throughout the study
* Use of alpha-receptor blockers within 2 weeks and throughout the study.
* Use of phytotherapy for BPH within 2 weeks and/or predicted to need phytotherapy during the study.
* Concurrent use of anabolic steroids
* Use of any alpha-adrenergic agonists or cholinergics within 48 hours prior to uroflowmetry assessment.
* Hypersensitivity to any 5a-reductase inhibitor or other chemically-related drugs.
* Actively trying to procreate or unwilling to wear a condom during intercourse with a woman of childbearing potential for duration of participation in this study and 16 weeks following treatment.
* History or current evidence of drug or alcohol abuse within the previous 12 months.
* History of any illness that in the opinion of the investigator might confound the results of the study or poses additional risk to the patient.
* Any unstable, serious co-existing medical condition(s) including, but not limited to, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, of cerebrovascular accident within 6 months prior to Screening visit; uncontrolled diabetes or peptic ulcer disease which is uncontrolled by medical management.
* History of renal insufficiency, or serum creatinine \>1.5xULN (Upper Limit of Normal )
* Participation in any investigational or marketed drug trial within 30 days and during the course of the study.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
50 Years
Study:
NCT00527605
Study Brief:
Protocol Section:
NCT00527605