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Treatment of Central Precocious Puberty by Subcutaneous Injections of Leuprorelin 3-Month Depot (11.25 mg)

Groupe Hospitalier Cochin-Saint Vincent de Paul (J.-C.C., O.J., C.T., J.L.C.), Faculté Cochin—Université Paris V and Institut National de la Santé et de la Recherche Médicale U342, Paris 75014, France; Laboratory of Hormonal Biochemistry (N.L.), Groupe Hospitalier Cochin-Saint Vincent de Paul, Paris 75014, France; Takeda Laboratories (V.M., C.L.), Puteaux 92800, France; and Centre d’Endocrinologie—Pédiatrique (M.C.), Bordeaux 33000, France

Address all correspondence and requests for reprints to: Prof. Jean-Claude Carel, Pediatric Endocrinology and Institut National de la Santé et de la Recherche Médicale U561, Groupe hospitalier Cochin-Saint Vincent de Paul, 82 av Denfert Rochereau, 75014 Paris, France. E-mail: . carel{at}cochin.inserm.fr

Abstract

Depot GnRH agonists are widely used for the treatment of precocious puberty. Leuprorelin 3-month depot is currently used in adults but has not been evaluated in children. We evaluated the efficacy of this new formulation (11.25 mg every 3 months), for the suppression of gonadotropic activation and pubertal signs in children with central precocious puberty. We included 44 children (40 girls) with early-onset pubertal development in a 6-month open trial. The inclusion criteria were clinical pubertal development before the age of 8 (girls) or 10 (boys), advanced bone age, enlarged uterus (>36 mm), testosterone more than 1.7 nmol/liter (boys), and pubertal response of LH to GnRH (peak >5 IU/liter). The principal criterion for efficacy assessment, GnRH-stimulated LH peak less than 3 IU/liter, was met in 81 of 85 (95%) of the tests performed at months 3 and 6. The remaining four values were slightly above the threshold. The levels of sex steroids were also significantly reduced and clinical pubertal development was arrested. Plasma leuprorelin levels, measured every 30 d, were essentially stable after d 60. Local intolerance was noted after 10 of 86 injections (12%), and was mild in four cases, moderate in five cases, and severe in one. Among these 10 events, 4 consisted in local pain at injection’s site. In conclusion, leuprorelin 3-month depot efficiently inhibits the gonadotropic axis in 95% of children with central precocious puberty studied for a 6-month period. This regimen allows the reduction of the number of yearly injections from 12 to 4.

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