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Phase 3 trial of a small-volume subcutaneous 6-month duration leuprolide acetate treatment for central precocious puberty

Journal of Clinical Endocrinology & Metabolism Sep 04, 2020

Klein KO, Freire A, Gryngarten MG, et al. - In this phase 3 multicenter, open-label, single-arm study, researchers sought to determine the effectiveness, pharmacokinetics, and safety of 6-month 45-mg subcutaneous leuprolide acetate for central precocious puberty (CPP). Sixty-four GnRHa-naïve children with CPP (age: 7.5 ± 0.1 years) received the study drug and 59 completed the study. Interventions included 2 doses of 45-mg subcutaneous leuprolide acetate (0.375 mL) at 0 and 24 weeks. Children have been followed for 48 weeks. At a 6-month period, a small volume of 45-mg subcutaneous leuprolide acetate effectively suppressed pubertal hormones and stopped or caused the regression of pubertal progression. For children with CPP, this long-acting GnRHa preparation of leuprolide acetate is a new, effective, and well-tolerated therapy.

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