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 solution for injection
INN or Proposed INN: TRIPTO
Sponsors
BEAUFOUR IPSEN PHARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • The child must have completed study 2 54 52014 143. • The child must have an effective response to 2 injections of triptorelin 11.25 mg according to investigator’s evaluation with no significant treatment side effects. • Written informed consent signed by both parents or by the liable parent or by the legal guardian when applicable. 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: • The patient has a known hypersensitivity to any of the test materials or related compounds • 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 with respect to the proportion of children who maintain a regression or stabilisation of sexual maturity until the end of the study.;Secondary Objective: • To assess the efficacy of triptorelin 11.25 mg on LH response to GnRH tests performed at M12, M24, M36, M48 and final visit (if applicable). • To assess the efficacy of triptorelin 11.25 mg on the FSH response to a GnRH test at M12, M24, M36, M48 and final visit (if applicable). • To assess the efficacy of triptorelin 11.25 mg on levels of oestradiol in girls or testosterone in boys, at M12, M24, M36 , M48 and final visit (if applicable) both measured by RIA. • To assess the efficacy of triptorelin 11.25 mg on bone maturation at M12, M24, M36, M48 and final visit (if applicable). • To assess the efficacy of triptorelin 11.25 mg on growth velocity at M12, M24, M36, M48 and final visit (if applicable). • To assess the variation of predicted adult height at M12, M24, M36, M48 and final visit (if applicable). • To assess the efficacy of triptorelin 11.25 mg on uterine length at M12, M24, M36, M48 and final visit (if applicable). • To assess the clinical safety of the drug. ;Primary end point(s): • Proportion of children with a stabilization or regression of Tanner pubertal stage at the end of the study, as compared to the stage at study entry (M6 of the phase III study 2 54 52014 143) • Pubertal stage variation at M12, M24, M36, M48 and final visit (if applicable). | — |
Countries
France
Outcome results
None listed