ESPE Yearbook of Paediatric Endocrinology

Brief Summary: This prospective study of 62 children with Central Precocious Puberty (CPP) concluded that measuring unstimulated luteinizing hormone (LH) may be adequate to assess effective pubertal suppression.

Pubertal stages, growth velocity and bone age maturation are considered as key clinical markers to evaluate adequate pubertal suppression in patients treated for CPP. Basal LH concentrations levels also seem to be effective¹. This study validated unstimulated LH level for assessing pubertal suppression in children with CPP.

Data were collected in patients enrolled in a phase 3 trial to assess efficacy and safety of a small-volume subcutaneous 6-Month Duration Leuprolide Acetate (LA)².

Unstimulated LH levels were < 1 IU/L in 84% and 86% of children at weeks 24 and 48 respectively. Eight children did not achieve unstimulated LH < 1 IU/L at week 24 but stopped pubertal stage progression and had stable or decreased bone age to chronological age ratio. Seven girls did not achieve stimulated LH <5 IU/L but none of them showed any progression in pubertal staging. A positive correlation was found between GnRH-stimulated and unstimulated LH at week 24 and 48 (( r 2 =0.508 and 0.550 respectively). No correlation was found between unstimulated LH and clinical endpoints.

This study reveals that unstimulated LH < 1 UI/L may serve as a marker of pubertal suppression in children with CPP treated with 6-month subcutaneous LA. However, the absence of correlation between LH concentrations and clinical growth endpoints highlights the need to integrate all clinical parameters with any biological data.

References: 1. Peter A Lee, Margaret Luce, Peter Bacher J. Monitoring treatment of central precocious puberty using basal luteinizing hormone levels and practical considerations for dosing with a 3-month leuprolide acetate formulation. Pediatr Endocrinol Metab. 2016; 29(11):1249-1257.2. Klein KO, Freire A, Gryngarten MG, Kletter GB, Benson M, Miller BS, Dajani TS, Eugster EA, Mauras N. Phase 3 Trial of a Small-volume Subcutaneous 6-Month Duration Leuprolide Acetate Treatment for Central Precocious Puberty. J Clin Endocrinol Metab. 2020;105(10):e3660-71.