Patient description: The patient is a 63-year-old man presenting to the Emergency Department with a history of acute urinary retention in the past 2 days. Abdominopelvic CT scan revealed a large prostate and a bladder filled with urine. He is a candidate for urethral catheterization and TURP. Further evaluation revealed: Post-void residual: 71 mL Prostate volume (TRUS): 63 mL Prostate-specific antigen (PSA) level: 3.5 ng/mL His recent blood chemistry (3 days ago) was normal: Hgb: 13.6 g/dl WBC: 133000 /mm3 Plt: 370000 /ml PT: 12 second PTT: 34 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative

Clinical trial eligibility criteria: eligible ages (years): 50.0-999.0,  Prostatic Hyperplasia A subject will be considered eligible for in this study only if all of the following apply males, aged ≥50 years clinical diagnosis of BPH by medical history and physical examination, including a digital rectal examination (DRE) International Prostate Symptom Score (IPSS) ≥12 points at Screening prostate volume ≥30 cc by transrectal ultrasonography; (TRUS) total serum Prostate Specific Antigen (PSA) ≥1.5ng/mL at Screening maximum flow rate (Qmax) >5 mL/sec and ≤15 mL/sec and minimum voided volume of ≥125 mL at Screening (based on two voids) willing and able to give written informed consent and comply with study procedures fluent and literate in local language with the ability to read, comprehend and record information on the IPSS, BII and Patient Perception of Study Medication able to swallow and retain oral medication  A subject will not be eligible for in this study if any of the following apply total serum PSA >10.0ng/mL at Screening history or evidence of prostate cancer (e.g. positive biopsy or ultrasound, suspicious DRE). Patients with suspicious ultrasound or DRE who have had a negative biopsy within the preceding 6 months and stable PSA are eligible for the study. Note: If total serum PSA is >4ng/mL and unless PSA value has been stable for at least the past 2 years, the investigator should make every appropriate effort to the possibility of prostate cancer, e.g. further DRE, review TRUS taken within previous month, consider 8-12 core prostate biopsy in accordance with routine clinical practice previous prostatic surgery (including TURP, balloon dilatation, thermotherapy and stent replacement) or other invasive procedures to treat BPH history of flexible/rigid cystoscopy or other instrumentation of the urethra within 7 days prior to the Screening Visit. Routine catheterisation is acceptable with no time restriction history of AUR within 3 months prior to Screening Visit post-void residual volume >250mL (suprapubic ultrasound) at Screening any causes other than BPH, which may in the judgement of the investigator, result in urinary symptoms or changes in flow rate (e.g. neurogenic bladder, bladder neck contracture, urethral stricture, bladder malignancy, acute or chronic prostatitis, or acute or chronic urinary tract infections) history of breast cancer or clinical breast examination finding of unclear origin or suggestive of malignancy use of any 5-alpha-reductase inhibitor (e.g. Proscar®, Propecia®, Avodart®), any drugs with antiandrogenic properties (e.g. spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, metronidazole, progestational agents), or other drugs which affect prostate volume, within past 6 months of the Screening Visit and throughout the study (other than as study medication)