Clinical trial NCT00564850: Efficacy and Safety Study of Pamoate of Triptorelin in Children With Precocious Puberty
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Precocious Puberty
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2007-11-28
Enrollment: 37
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With a GnRH-stimulated LH Level ≤3 IU/L
timeFrame: 3 months after the first injection of triptorelin pamoate 11.25 mg
Secondary outcomes:
measure: Number of Participants Whose Intravenous (i.v.) GnRH-stimulated LH Response Was ≤3 IU/L
timeFrame: Month 6
measure: Follicle Stimulating Hormone (FSH) Level Following GnRH Test
timeFrame: Screening, month 3 and 6
measure: Basal FSH Level
timeFrame: Month 0, 1, 2, 3, 4, 5, and 6
measure: Basal LH Level
timeFrame: Month 0, 1, 2, 3, 4, 5 and 6
measure: Number of Girls With Oestradiol Levels ≤ 20 pg/ml
timeFrame: Month 0, 1, 2, 3, 4, 5 and 6
measure: Testosterone Level
timeFrame: Month 0, 3 and 6
measure: Number of Girls With Inhibin B Levels < 6 pg/ml
timeFrame: Month 0, 3 and 6
measure: Change From Screening in Pubertal Stage (Tanner Method) at Month 6
timeFrame: Between screening and month 6
measure: Height Standard Deviation Score (SDS)
timeFrame: Month 0, 3 and 6
measure: Body Mass Index (BMI) SDS
timeFrame: Month 0, 3 and 6
measure: Change From Baseline in Growth Velocity (GV) SDS at Month 6
timeFrame: Baseline and month 6
measure: Difference Between Bone Age and Chronological Age
timeFrame: Month 0 and 6
measure: Uterine Length
timeFrame: Month 0, 3 and 6
measure: Triptorelin Plasma Levels
timeFrame: Month 1, 2, 3, 4, 5 and 6
Other outcomes:
Locations:
city: Angers
country: France
facility: Hôpital Hotel-Dieu (CHU)
city: Besancon
country: France
facility: Hôpital Saint-Jacques
city: Bordeaux
country: France
facility: Medical Centre
city: Dijon
country: France
facility: Hôpital du Bocage
city: Le Havre
country: France
facility: Hôpital Flaubert
city: Lille
country: France
facility: Hôpital Jeanne de Flandre
city: Lyon
country: France
facility: Hôpital Debrousse
city: Marseille
country: France
facility: Hôpital de la Timone Enfants
city: Nice
country: France
facility: Hôpital Archet 2
city: Paris
country: France
facility: Hôpital Trousseau
city: Paris
country: France
facility: Hôpital St-Vincent de Paul
city: Paris
country: France
facility: Hôpital Necker - Enfants Malades
city: Paris
country: France
facility: Hôpital Robert Debré
city: Reims
country: France
facility: American Memorial Hospital
city: Rouen
country: France
facility: Hôpital Charles Nicolle
city: Strasbourg
country: France
facility: Hôpital Hautepierre
city: Tarbes
country: France
facility: Hôpital de la Gespe
city: Toulouse
country: France
facility: Hôpital des Enfants
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: