A Major Change? 6-Monthly Leuprolide for Central Precocious
Gonadotropin-releasing hormone agonists (GnRHas) are standard of care for central precocious puberty (CPP). A 6-month subcutaneous injection has recently been approved by the Food and Drug Administration.

This study aimed to determine efficacy, pharmacokinetics, and safety of 6-month 45-mg subcutaneous leuprolide acetate for CPP. This was a phase 3 multicenter, open-label, single-arm study.

In 25 sites in 6 countries, 64 GnRHa-naïve children with CPP (age: 7.5 ± 0.1 years) received study drug: 59 completed the study. 2 doses of 45-mg subcutaneous leuprolide acetate (0.375 mL) at 0 and 24 weeks; children were followed for 48 weeks.

-- 54/62 (87%) children achieved poststimulation LH <4 IU/L at week 24; 49/56 (88%) girls and 1/2 boys maintained peak LH <4 IU/L at week 48.

-- Mean growth velocity decreased from 8.9 cm/year at week 4 to 6.0 cm/year at week 48.

-- Mean bone age was advanced 3.0 years beyond chronological age at screening and 2.7 years at week 48.

-- Breast pubertal stage regressed or was stable in 97% of girls and external genitalia development regressed in both boys.

-- Adverse events were mild and did not cause treatment discontinuation.

Conclusively, a small volume of 45-mg subcutaneous leuprolide acetate administered at a 6-month interval effectively suppressed pubertal hormones and stopped or caused regression of pubertal progression. This long-acting GnRHa preparation of leuprolide acetate is a new, effective, and well-tolerated therapy for children with CPP.

Source: https://academic.oup.com/jcem/article/105/10/e3660/5879679