Treatment of Central Precocious Puberty with Triptorelin 11.25 mg Depot Formulation

Abstract

A new triptorelin 11.25 mg long depot formulation is now available for the treatment of central precocious puberty (CPP). The aim of our study was to evaluate the efficacy of triptorelin 11.25 mg administered every 90 days to suppress gonadotropin and sex steroid secretion and pubertal signs in children with CPP during 2 years of treatment. Inclusion criteria were clinical pubertal development before the age of 8 years in girls or 9 years in boys, advanced bone age and a pubertal LH response (peak >5 mIU/ml) to GnRH. We studied 20 patients (19 girls and 1 boy), with a median age at entry into the study of 7.5 +/- 0.2 years for girls, and 9 years for the boy. The basal and GnRH-stimulated serum levels of LH and FSH decreased significantly from baseline to 3 months of therapy (p <0.0001). All patients had a GnRH-stimulated peak below 3 mIU/ml between 6 and 24 months of treatment. The pituitary-gonadal axis recovered adequately after discontinuation of therapy. These results suggest that 3-month depot triptorelin is a satisfactory alternative for the therapy of children with CPP. The longer interval between injections may increase acceptability and compliance with treatment.

Central Precocious Puberty: Adult Height in Girls Treated with Quarterly or Monthly Gonadotropin-Releasing Hormone Analog Triptorelin

“…In short-term trials, quarterly triptorelin demonstrated its efficacy in suppressing gonadotropin secretion to prepubertal levels in the large majority of treated children [8,9,10]. In addition, we reported that triptorelin 11.25 mg was able to suppress LH peak during a standard GnRH test to a similar extent as the 3.75 mg formulation at 3 and 6 months of follow-up [18], suggesting that the two triptorelin preparations are likely equivalent, at least in terms of gonadotropin suppression in girls with CPP.…”

“…In addition, we reported that triptorelin 11.25 mg was able to suppress LH peak during a standard GnRH test to a similar extent as the 3.75 mg formulation at 3 and 6 months of follow-up [18], suggesting that the two triptorelin preparations are likely equivalent, at least in terms of gonadotropin suppression in girls with CPP. However, these trials were limited to 6-24 months of follow-up [8,9,10,19]. …”

“…Quarterly formulations of GnRH analogs have been developed [2], and short-term trials showed their efficacy in suppressing the hypothalamic-pituitary-gonadal (HPG) axis in children with CPP [7,8,9,10,11,12,13,14,15,16,17], but long-term follow-up until AH is rarely reported [7]. At our knowledge, long-term comparative data of girls treated with monthly or quarterly formulations of the GnRH analog triptorelin are not available.…”

Meta-Analysis of Paediatric Patients with Central Precocious Puberty Treated with Intramuscular Triptorelin 11.25 mg 3-Month Prolonged-Release Formulation

“…Children recruited to the studies analysed in the meta-analysis met the following criteria: proven CPP defined as onset of sex characteristics development before the age of 8 years in girls and 9 years in boys based on the Tanner criteria consensus statement definition [1-3], with a pubertal response of LH to LH-releasing hormone in both sexes (stimulated LH >5 IU/L in Martinez-Aguayo et al [10] and Zenaty et al [11]; >6 IU/L in Bertelloni et al [8] or >7 IU/L in Carel et al [4] and Chiocca et al [9]), and a bone age >1 year ahead of the chronological age. As this was a retrospective study, no further ethical approval was sought beyond that obtained for all patients in the original studies.…”

Urinary Metabolite Markers of Precocious Puberty

“…Correct diagnosis of the etiology of sexual precocity is critical, because treatment of patients with PPP is different from those with CPP, and some PPP can secondarily evolve into CPP (6). Standard treatment of CPP is to suppress the activation of HPGA (7) through periodically using GnRH agonists such as leuprorelin depot (8) and triptorelin depot (9,10). Patients with CPP have to continue receiving this medication until they reach the average age of the onset of puberty.…”