According to a report by BioSpace, results from a phase III study assessing the use of cetrorelix for benign prostatic hyperplasia (BPH) did not meet the primary efficacy endpoint of improving International Prostate Symptom Score (IPSS).

The multi-centre study, Z-036, involved a total of 420 patients who were randomised to receive cetrorelix by intra-muscular (IM) injection at weeks 0, 2, 26 and 28 (for treatment Arm A n=212), those in Arm B received IM injection at weeks 0, 2 and placebo injections both at weeks 26 and 28 (n=106), and patients in treatment Arm C received placebo injections at weeks 0, 2, 26 and 28 (n=102).

The results showed that there were no clear differences in overall efficacy, with all 3 groups (including placebo) showing an improvement in IPSS of approximately 6 points that was maintained throughout the 52 weeks of follow-up.

[Editors note: Cetrorelix is currently only licensed for prevention of premature ovulation in patients undergoing a controlled ovarian stimulation, followed by oocyte pick-up and assisted reproductive techniques.]