E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10058084 |
E.1.2 | Term | Precocious puberty |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
*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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of children with a negative LH response to GnRH test at M3 (stimulated LH < or = 3 IU/l). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 19 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |