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 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT00472251
Eligibility Criteria:
Inclusion Criteria:
* Male patients with symptomatic BPH
* Prostate volume of 30 cm3 or greater measured by transrectal ultrasound
* International Prostatic Symptom Score(IPSS) of 9 or greater
* Maximum urinary flow rate (Qmax) of 15ml/s or less
* No definite evidence of prostate cancer (on transrectal ultrasound, DRE, or etc.)
* Given Informed consent
Exclusion Criteria:
* Post-void residual more than 250 mL
* History of cancer (including prostate cancer) or previous prostatic surgery
* Acute urinary retention within 3 months of enrollment
* Chronic alcohol abuser and heavy smoker (\> 10 cigarettes/day)
* History of/current drug abuse including laxatives
* Any previous 5 ARI administration
* Type 1 DM or Type 2 DM regardless of treatment
* Clinically significant endocrine diseases at investigator's discretion including thyroid diseases.
* History of /current bulimia or anorexia nervosa
* Regular use of following prohibited medicines within 3 months prior to screening; A. Medicines which can affect salt/water retention such as diuretics, calcium channel blockers, gabapentin, pregabalin, etc B. Medicines which can affect body weight such as sibutramine, orlistat, phentermine, amphetamine, etc.
C. Anti-thyroid medication, thyroxine, cyproheptadine, tranquilizers, systemic corticosteroids, testosterone supplement, or other medications that are known to affect body weight or BMI
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
45 Years
Maximum Age:
75 Years
Study:
NCT00472251
Study Brief:
Protocol Section:
NCT00472251