An Open-label, Single Arm, Multicenter Study on the Efficacy, Safety, and Pharmacokinetics of Leuprolide Acetate 45 mg for Injectable Suspension Controlled Release in Subjects With Central (Gonadotropin-Dependent) Precocious Puberty

CompletadoFase 3ClinicalTrials.gov

ID: NCT02452931Tipo: INTERVENTIONALInicio: 31 de ago de 2015Fin estimado: 5 de sept de 2018

Traducción no disponible, mostrando original

Resumen

This study determines the effectiveness of leuprolide acetate 45 mg for injectable suspension for treatment of children with Central Precocious Puberty.

Descripción detallada

Leuprolide acetate is a GnRH agonist that inhibits pituitary gonadotropin secretion by binding to the GnRH receptors and blocking downstream hormone synthesis. The steady decrease in hormone synthesis (LH and FSH) leads to a suppression of testicular and ovarian steroidogenesis. In children with CPP, this steady decrease in hormone synthesis disrupts the progression of puberty.

Elegibilidad

Edad mínima: 2 YearsEdad máxima: 9 YearsSexo: ALL

Criterios de inclusión

Females age 2 to 8 years (inclusive) or males age 2 to 9 years (inclusive)
Confirmed diagnosis of CPP within 12 months of Baseline Visit (Day 0) but have not received prior GnRH agonist treatment for CPP
Pubertal-type LH response following an abbreviated GnRHa stimulation test before treatment initiation
Clinical evidence of puberty, defined as Tanner stage ≥ 2 for breast development in females or testicular volume ≥ 4 mL in males
Difference between bone age (Greulich and Pyle method) and chronological age ≥ 1 year

Criterios de exclusión

Gonadotropin-independent (peripheral) precocious puberty
Prior or current GnRH treatment for CPP
Prior or current therapy with medroxyprogesterone acetate, growth hormone or insulin-like growth factor-1 (IGF-1)
Diagnosis of short stature (ie, 2.25 standard deviations (SD) below the mean height for age)
Known history of seizures, epilepsy, and/or central nervous system disorders that may be associated with seizures or convulsions
Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study

Intervenciones

drug

Leuprolide Acetate 45 mg

Subcutaneous injection

Ubicaciones

Hospital de Ninos

Buenos Aires, Argentina

Patrocinadores

PrincipalTolmar Inc.

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