Precocious Puberty MedDRA version: 9.1 Level: LLT Classification code 10058084 Term: Precocious puberty
Conditions
Interventions
Trade Name: DECAPEPTYL LP 11,25 mg (triptorelin as pamoate)
Product Name: triptorelin
Product Code: 52014
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: trip
Sponsors
BEAUFOUR IPSEN PHARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient’s 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 = or > 20 kg. - Written informed consent signed by both parents or by the liable parent or by the legal guardian when applicable - Registration to a social security. - Non participation to another study. Patient’s 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 and could be included in the study less than 9 years for girls and 10 years for boys. A pubertal response of LH to GnRH test in both sexes (stimulated LH = or > 5 IU/l). - Difference Bone age (BA) (according to Greulich et Pyle method) – Chronological age (CA) > 1 year. - Testosterone level = or > 0.5 ng/ml in boys. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 = or >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. - The patient has received an unlicensed drug, within the last 3 months. - The patient has a known hypersensitivity to any of the test materials or related compounds. - The patient has any concomitant significant disease that is likely to interfere with the study (malignancy, chronic disease). - The patient is unable or unwilling to comply fully with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of Triptorelin 11.25 mg pamoate with respect to the proportion of children with suppressed LH response (LH < or = 3 UI/l) to GnRH test performed 3 months (M3) after injection with Triptorelin 11.25 mg.;Secondary Objective: *the proportion of children with : -the FSH response to a GnRH test at M3, M6,and LH response (LH < or = 3 IU/l) to GnRH test performed at M6. -estradiol level < or = 20 pg/ml in girls, testosterone (< or = 0.3 ng/ml) in boys at M1 M2 M3 M4 M5 and M6. -Inhibin B (girls) level < or = 6 pg/ml at M3 and M6. -FSH and LH levels at M1 M2 M3 M4 M5 and M6. -stabilisation of sexual maturation (Tanner Method) at M3 and M6. -height, weight and growth velocity at M3 and M6. -the bone age maturation at M6. -regression within pre-pubertal ranges of the uterine length at M3 and M6. *the plasma levels of triptorelin at Baseline, M1 M2 M3 M4 M5 and M6. *the safety profile of the drug.;Primary end point(s): Proportion of children with a negative LH response to GnRH test at M3 (stimulated LH < or = 3 IU/l). | — |
Countries
France
Outcome results
None listed