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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
One intra muscular injection at day 1 and month 3.
Hôpital Hotel-Dieu (CHU)
Angers, France
Hôpital Saint-Jacques
Besançon, France
Medical Centre
Bordeaux, France
Number of Participants With a GnRH-stimulated LH Level ≤3 IU/L
Time frame: 3 months after the first injection of triptorelin pamoate 11.25 mg
Number of Participants Whose Intravenous (i.v.) GnRH-stimulated LH Response Was ≤3 IU/L
Time frame: Month 6
Follicle Stimulating Hormone (FSH) Level Following GnRH Test
Time frame: Screening, month 3 and 6
Basal FSH Level
Time frame: Month 0, 1, 2, 3, 4, 5, and 6
Basal LH Level
Time frame: Month 0, 1, 2, 3, 4, 5 and 6
Number of Girls With Oestradiol Levels ≤ 20 pg/ml
Time frame: Month 0, 1, 2, 3, 4, 5 and 6
Testosterone Level
Time frame: Month 0, 3 and 6
Number of Girls With Inhibin B Levels < 6 pg/ml
Time frame: Month 0, 3 and 6
Change From Screening in Pubertal Stage (Tanner Method) at Month 6
Pubertal stage (graded from 1 to 5 for penis and breast development, graded from 1 to 6 for pubic hair development) according to the Tanner method was collected. A low stage (i.e. 1) corresponds to a pre-pubertal stage and a high stage (i.e. 5 or 6) to an adult stage. Any increase of grade was defined as 'increased' and no change in grade or a reduced grade was defined as 'stabilised or reduced'.
Time frame: Between screening and month 6
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Hôpital du Bocage
Dijon, France
Hôpital Flaubert
Le Havre, France
Hôpital Jeanne de Flandre
Lille, France
Hôpital Debrousse
Lyon, France
Hôpital de la Timone Enfants
Marseille, France
Hôpital Archet 2
Nice, France
Hôpital Trousseau
Paris, France
...and 8 more locations
Height Standard Deviation Score (SDS)
Standard deviation (SD) is a standard term used in growth studies and represents Standard Deviations calculated as the patient value minus the mean divided by the standard deviation. Standard Deviation Scores vary depending on the age and sex of the child.
Time frame: Month 0, 3 and 6
Body Mass Index (BMI) SDS
Time frame: Month 0, 3 and 6
Change From Baseline in Growth Velocity (GV) SDS at Month 6
Change from baseline of GV was calculated as: GV at month 6 - GV at baseline. GV SDS was calculated using SAS algorithm. Growth velocity during the study was calculated using the two height measures as: GV = (Height at baseline - Height at screening)\*365/delay between two height measures.
Time frame: Baseline and month 6
Difference Between Bone Age and Chronological Age
Bone age was defined according to Greulich and Pyle method. Chronological age was calculated using the date of birth.
Time frame: Month 0 and 6
Uterine Length
Time frame: Month 0, 3 and 6
Triptorelin Plasma Levels
Time frame: Month 1, 2, 3, 4, 5 and 6