|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
EUCTR |
|
Last refreshed on:
|
4 April 2022 |
|
Main ID: |
EUCTR2005-005644-11-FR |
|
Date of registration:
|
10/05/2007 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
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 - NA
|
|
Scientific title:
|
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 - NA |
|
Date of first enrolment:
|
05/07/2007 |
|
Target sample size:
|
36 |
|
Recruitment status: |
Not Recruiting |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-005644-11 |
|
Study type:
|
Interventional clinical trial of medicinal product |
|
Study design:
|
Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
|
|
Phase:
|
Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion 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:
- 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.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
|
|
Health Condition(s) or Problem(s) studied
|
Precocious Puberty
MedDRA version: 9.1
Level: LLT
Classification code 10058084
Term: Precocious puberty
|
|
Intervention(s)
|
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: triptorelin
CAS Number: 57773-63-4
Current Sponsor code: 52014
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 11.25-
|
|
Primary Outcome(s)
|
|
Primary end point(s): Proportion of children with a negative LH response to GnRH test at M3 (stimulated LH < or = 3 IU/l).
|
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.
|
|
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 ID(s)
|
|
2-54-52014-143
|
|
Source(s) of Monetary Support
|
|
Ethics review
|
Status: Approved
Approval date: 05/07/2007
Contact:
|
|