Efficacy and Safety of Triptorelin 3-Month Formulation in Chinese Children with Central Precocious Puberty: A Phase 3, Open-Label, Single-Arm Study.
Adv Ther
; 40(10): 4574-4588, 2023 10.
Article
en En
| MEDLINE
| ID: mdl-37584898
Central precocious puberty (CPP) occurs when the reproductive organs and secondary sexual characteristics develop too early in children (before 8 years old in girls or 9 years old in boys). It can cause significant psychological harm and may lead to health problems later in life. Triptorelin is a type of treatment designed to suppress the hormonal activity responsible for CPP and therefore slow down early pubertal development. Triptorelin can be given as an injection into muscle every month or every 3 months; the 3-monthly formulation is commonly used in many countries but at the time of this study it was not licensed for patients with CPP in China. Our trial assessed the effect of triptorelin treatment every 3 months for 1 year in 32 Chinese children with CPP. For all patients who had measurements available, 3-monthly triptorelin suppressed luteinizing hormonea key hormone involved in CPPto below typical prepubertal levels. Other hormones involved in puberty were also suppressed. Children experienced a slowing down of the development of secondary sexual characteristics (breasts, genitals and pubic hair), and stabilization or reduction in the size of internal sexual organs (uterine length in girls and testicular volume in boys). Their height also increased less rapidly than previously. There were no concerning side effects of triptorelin treatment, and the safety profile matched that seen in other countries where triptorelin is widely used for CPP. Overall, our study findings suggest that the 3-monthly triptorelin formulation may be a good option for Chinese children with CPP.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Asunto principal:
Pubertad Precoz
/
Pamoato de Triptorelina
Tipo de estudio:
Observational_studies
Límite:
Child
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Child, preschool
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Female
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Humans
/
Male
Idioma:
En
Revista:
Adv Ther
Asunto de la revista:
TERAPEUTICA
Año:
2023
Tipo del documento:
Article
País de afiliación:
China