Efficacy and Safety Study of Pamoate of Triptorelin in Children With Precocious Puberty

Phase III, Multicentre, Non-comparative, Open and Single Stage Study to Assess the Efficacy and Safety of Pamoate of Triptorelin 11.25 MG in Children With Precocious Puberty

The purpose of the study is to assess the efficacy of triptorelin 11.25 mg pamoate in the delay of premature onset of puberty in girls less than 9 years and boys less than 10 years. This is measured by assessing the proportion of children who have a suppressed Luteinizing Hormone (LH) response to Gonadotropin Releasing Hormone (GnRH) test performed 3 months after injection with triptorelin 11.25 mg.

Inclusion Criteria in the screening phase:

• Onset of sex characteristics (Tanner method) breast development in girls or testicular enlargement in boys before the age of 8 years in girls and 9 years in boys.
• Weight ≥ 20 kg.

Inclusion Criteria in the treatment phase:

• Proven central precocious puberty defined as onset of sex characteristics development (according to Tanner method) diagnosed before the age of 8 years in girls and 9 years in boys.
• Age at evaluation less than 9 years for girls and 10 years for boys.
• A pubertal response of LH to GnRH test in both sexes (stimulated LH ≥ 5 IU/l).
• Difference Bone age (BA) (according to Greulich et Pyle method) - Chronological age (CA) > 1 year.
• Testosterone level ≥ 0.5 ng/ml in boys.

Exclusion Criteria:

• Patient with a peripheral precocious puberty: extrapituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroids secretion.
• Patient with a cerebral tumour requiring a neurosurgery or cerebral irradiation.
• Patient with a Body Weight ≥ 125% of the ideal weight for the height and age (growth curves).
• The patient has received a previous treatment with a GnRH analogue, or medroxyprogesterone or cyproterone acetate.