Phase 2 Study of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) (Enlarged Prostate)
Phase 2 Multicenter Randomized Two Dose Level and Non-Inferiority Clinical Evaluation of Transrectal Administration of NX-1207 for the Treatment of BPH
This completed study evaluated the safety and efficacy of two dose levels of NX-1207 for the treatment of BPH (benign prostatic hyperplasia) versus finasteride.
Subjects randomized to NX-1207 were blinded as to the dose level of NX-1207 they received.
Therapeutic dose; single intraprostatic injection of 2.5 mg NX-1207
Low dose; single intraprostatic injection of 0.125 mg NX-1207
Active comparator; 5.0 mg finasteride p.o. q.d. for duration of study (180 days)
Inclusion Criteria: Documented history of BPH for at least 1 year AUA SI ≥ 15 Prostate Volume ≥ 30 mL ≤ 70 mL Qmax < 15 mL/sec Exclusion Criteria: History of illness or condition that may interfere with study or endanger subject Use of prescribed medications that may interfere with study or endanger subject Presence of a median lobe of the prostate Surgery or MIST in the previous 12 months for treatment of BPH Post-void residual urine volume > 350 mL PSA ≥ 10 ng/mL; prostate cancer must be ruled out for PSA ≥ 4 ng/mL