Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)
Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)
This study will evaluate the safety and efficacy of a 2.5 mg dose of NX-1207 for the
 treatment of BPH (benign prostatic hyperplasia) as compared to placebo.
Inclusion Criteria:

 1. Provide signed informed consent prior to enrolment in the study

 2. IPSS ≥ 15

 3. Prostate Volume ≥ 30 mL ≤ 70 mL

 4. Qmax < 15 mL/sec based on a minimum void of 125 mL

 5. Agree not to use any other approved or experimental BPH or OAB medication anytime
 during the study

 Exclusion Criteria:

 1. History of illness or condition that may interfere with study or endanger subject

 2. Use of prescribed medications that may interfere with study or endanger subject

 3. Presence of a median lobe of the prostate

 4. Previous surgery or MIST for treatment of BPH

 5. Post-void residual urine volume > 200 mL

 6. PSA ≥ 10 ng/mL; prostate cancer must be ruled out (negative biopsy) for PSA ≥ 4 ng/mL

 7. Participation in a study of any investigational drug or device within the previous 90
 days

 8. Prostate cancer