AEterna Zentaris initiates dosing for Phase III BPH trial

This 500-patient safety trial is the third of three Phase III studies, planned to enroll a total of 1,500 patients, to define the role of cetrorelix in the treatment of benign prostatic hyperplasia (BPH).

The safety study will assess an intermittent dosage regimen of cetrorelix pamoate as a potential safe and tolerable treatment providing prolonged improvement in BPH-related signs and symptoms. Patients will receive cetrorelix pamoate by intra-muscular injection at weeks zero and two, and will be followed up to week 26. The main endpoint is the incidence of possibly drug-related adverse events.