Placebo-controlled dose-ranging phase 2 study of subcutaneously administered LHRH antagonist cetrorelix in patients with symptomatic benign prostatic hyperplasia.

Background: Pilot studies with daily dosing suggested the use of the luteinizing hormone-releasing hormone antagonist cetrorelix (CET) for the treatment of symptoms from benign prostatic hyperplasia (BPH).

Objective: To assess efficacy and safety of three dosing schemes of CET in patients with symptomatic BPH.

Design, Setting And Participants: After a run-in period with 4 weekly injections of placebo, 140 patients with an international prostate symptoms score (IPSS) > or =13 and a peak urinary flow rate (PFR) 5-13ml/s were randomly allocated to 4 treatment groups; patients with residual urine volume of >350ml were excluded.