Patient description: The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 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,  Benign Prostatic Hyperplasia (BPH) (All must be answered yes): 1. Has the patient given written informed consent? 2. Is the patient at least 50 years old? 3. Is the patient diagnosed with BPH and has he had clinical signs and symptoms of BPH for ≥ 6 months? 4. Does the patient have an IPSS ≥ 13? 5. Does the patient have a peak urinary flow rate (Qmax) of 4-15 mL/sec (utilizing the 2-second rule) established on a voided volume of at least 125 mL? 6. Does the patient have an IPSS QoL score of ≥ 3? 7. Does the patient have a PSA > 0.8 ng/mL? 8. For patients with a PSA between 4 and 10 ng/mL or suspicion of prostate cancer, has the patient had a diagnostic evaluation (e.g., biopsy, PSA, velocity, etc.) that reasonably excludes the diagnosis of prostate cancer? 9. Is the patient willing to agree not to use any other approved or experimental pharmacologic BPH treatments including but not limited to alpha blockers, 5-alpha reductase inhibitors, anti-cholinergic preparations or herbal preparations at any time during the study? 10. Is the patient willing to restrict use of PDE 5 inhibitors exclusively to the use of Viagra, one dose per week only and with no dosing in the 5 days immediately preceding scheduled study visit? 11. Is the patient willing and able to abide by the protocol? 12. Does the patient have an IPSS ≥ 13? 13. Does the patient have an IPSS QoL score of ≥ 3? 14. Does the patient have a post-void residual ≤ 350cc?  (all must be answered No): 1. Does the patient have a history of prostate cancer or a serum PSA >10 ng/mL? 2. Has the patient had prior prostate or bladder surgery, pelvic surgery (excluding hernia repair), pelvic radiation or lower urinary tract malignancy? 3. Does the patient have a prevoid total bladder volume assessed by ultrasound > 550 mL? 4. Does the patient have a post void residual urine volume ≥ 350 mL by ultrasound? 5. Has the patient taken or is the patient currently taking any of the following: 1. Estrogens, phytoestrogens, androgens, antiandrogens or LHRH agonists within the past 4 months (e.g. testosterone gel [Androgel ®1%, Testim ® 1%], testosterone buccal [Striant®], oxymetholone [Anadrol®-50], oxandrolone [Oxandrin®], esterified estrogen and methyltestosterone [Estratest®]), bicalutamide [Casodex®], nilutamide [Nilandron®], flutamide [Eulexin®], leuprolide acetate [Lupron®, Eligard®, Viadur®], goserelin acetate [Zoladex®] or, 2. 5 α-reductase inhibitors within the past 4 months (e.g. finasteride[Proscar®, Propecia®], dutasteride [Avodart®]) or, 3. Alpha blockers or anti-cholinergic preparations within the past 6 weeks (e.g. doxazosin [Cardura®], terazosin [Hytrin®], tamsulosin [Flomax®], alfuzosin [Uroxatrol®], oxybutinin [Ditropan®], tolteredine [Detrol-LA®], amytriptyline [Elavil®, Limbitrol®]) or, 4. Class 1A (e.g. quinidine, procainamide, disopyramide) or Class III Anti-arrhythmic (e.g.sotalol [Betapace®], amiodarone [Cordarone®]) 6. Does the patient have or has the patient ever had a diagnosis of acute or chronic prostatitis or chronic pelvic pain syndrome? 7. Has the patient had a urinary tract infection or instrumentation (e.g catheterization, cystoscopy, prostate biopsy) within the past 4 weeks? 8. Does the patient have a history of urethral stricture, bladder stones, obstructing median lobe or neurogenic bladder dysfunction? 9. Does the patient have microscopic hematuria greater than trace by dipstick urine at Visit 1? 10. Did the patient have a positive drug screening result? 11. Does the patient have a history of urinary retention? 12. Does the patient have any serious medical condition (e.g., CHF, poorly controlled diabetes (HgbA1c > 9), psychiatric disorder, drug or alcohol abuse) that might interfere with his ability to comply with or complete the protocol? 13. Is the patient's QTc interval on the screening ECG > 450ms, or does he have a family history of long QT syndrome? 14. Does the patient anticipate or plan to have an elective surgery or surgical procedure requiring general, spinal or epidural anesthesia during the course of the double-blind treatment portion of the study(within the next 12 months)? 15. Has the patient ever received ozarelix, cetrorelix, tevarelix or degarelix? 16. Has the patient participated in any other study of an investigational drug or treatment for the signs and symptoms LUTS or BPH in the past 12 months? 17. Has the patient participated in any other clinical research study or study of an investigational drug in the past 90 days?