This multicenter, open, non-comparative, Phase III study showed that 97.5% of patients achieved castrate levels of serum testosterone 28 days after the first injection and that 93% of the patients maintained serum testosterone levels below castrate level (defined as < 1.735 nmol/L or 50 ng/dL) from week eight to 48. These efficacy results are similar to those obtained previously with repeated administrations of the one- and three-month formulations of triptorelin. Furthermore the adverse event profile of the new six-month formulation of triptorelin is fully comparable to that observed with the one- and three-month formulations.