Study to Evaluate Efficacy and Safety of NDS-446 in Men With Lower Urinary Tract Symptoms (LUTS)
Study to Evaluate Efficacy and Safety of NDS-446 in Men With Lower Urinary Tract Symptoms (LUTS)
Prospective, Randomized, Double-Blind, Placebo Controlled clinical trial to study the
 efficacy and the safety of NDS-446 (500 mg/cap) in Men 45 years of age or older with moderate
 to severe lower urinary tract symptoms (LUTS)
Inclusion Criteria:

 1. Men ≥45 years of age.

 2. LUTS, based on IPSS total score ≥8 and <25

 3. Peak urinary flow rate (Qmax) ≥4 and ≤15 mL/sec at screening

 4. Post Void Residual (PVR) urine volume ≤ 200 mL at screening

 5. PSA level at screening < 10 ng/mL. Subjects with a PSA > 4ng/mL and < 10 ng/mL are
 eligible only if prostate cancer has been ruled out

 6. Subjects who understand and speak English

 7. Able and willing to give informed consent and comply with all study protocol
 procedures (diaries and other study tools).

 Exclusion Criteria:

 1. Not suitable for medical intervention (e.g., requiring TURP, etc.)

 2. History of interstitial cystitis, bladder stones, urethral stricture, current
 prostatitis, acute urinary retention requiring catheterization in the last 3 months,
 or any other condition suspected to be the cause of LUTS other than BPH

 3. Screening serum Creatinine (Cr) or liver function tests [ALT (SGPT), AST (SGOT)] > 3
 times the upper limit of normal (ULN) confirmed on a second measurement.

 4. Cancer of the prostate or bladder by history or current diagnosis.

 5. Prostate nodule(s) on screening digital rectal exam (DRE).

 6. Prior surgical procedure of the urinary tract such as TURP, laser prostatectomy,
 photovaporization of the prostate

 7. No minimally invasive surgery to the prostate such as TUMT or TUNA within the last 6
 months.

 8. Active urinary tract infection.

 9. Unstable or uncontrolled medical or psychiatric condition.

 10. Abnormal screening labs > 2 times the upper limit of normal (ULN) [for all parameters
 other than those listed for exclusion criteria#3]

 11. Myocardial infarction or CVA within the past 90 days.

 12. Requiring ongoing administration of antibiotics, antifungals, antiviral, chemotherapy,
 steroidal or immunosuppressive treatments.

 13. Requiring chronic administration of aspirin at a dose >81 mg/day.

 14. Known hypersensitivity to study drug ingredient(s) or allergy to berries.

 15. Use of the following medications: alpha blockers (28 days of screening), herbal or
 nutritional BPH supplements (28 days of screening), OAB medications (28 days of
 screening), 5 alpha reductase inhibitors (175 days of screening), PDE5 inhibitors
 (permitted as needed for erectile dysfunction only, but not to exceed 1 dose per week
 and not to be dosed within 5 days of a visit)

 16. Use of an investigational agent (drug, biologic, device, etc.) within 30 days of
 screening

 17. Any reason or condition that in the judgment of the Clinical Investigator(s) may put
 the subject at unacceptable risk or that may preclude the subject from understanding
 or complying with the study's requirements.