Efficacy and Safety of a Single TRUS-guided Intraprostatic Injection of NX-1207 in Patients With LUTS Due to BPH
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
The purpose of the this international, multicenter, randomised, single-blind, parallel group,
Phase III study is to demonstrate that a single transrectal ultrasound (TRUS)-guided
intraprostatic injection of NX-1207 provides a long lasting therapeutic improvement of Lower
Urinary Tract Symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH) in patients
not adequately controlled by medical therapy with α-blockers, as assessed by a change from
baseline in the International Prostate Symptom Score (IPSS) total score.
Phase:
Phase 3
Details
Lead Sponsor:
RECORDATI GROUP Recordati Industria Chimica e Farmaceutica S.p.A.