Efficacy and Safety Study of Pamoate of Triptorelin in Children With Precocious Puberty
- Conditions
- Precocious Puberty
- Interventions
- Registration Number
- NCT00564850
- Lead Sponsor
- Ipsen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
Not provided
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Triptorelin pamoate 11.25mg (Decapeptyl® SR) Triptorelin pamoate 11.25mg (Decapeptyl® SR) -
- Primary Outcome Measures
Name Time Method Number of Participants With a GnRH-stimulated LH Level ≤3 IU/L 3 months after the first injection of triptorelin pamoate 11.25 mg
- Secondary Outcome Measures
Name Time Method Basal FSH Level Month 0, 1, 2, 3, 4, 5, and 6 Number of Girls With Oestradiol Levels ≤ 20 pg/ml Month 0, 1, 2, 3, 4, 5 and 6 Number of Participants Whose Intravenous (i.v.) GnRH-stimulated LH Response Was ≤3 IU/L Month 6 Difference Between Bone Age and Chronological Age Month 0 and 6 Bone age was defined according to Greulich and Pyle method. Chronological age was calculated using the date of birth.
Basal LH Level Month 0, 1, 2, 3, 4, 5 and 6 Change From Baseline in Growth Velocity (GV) SDS at Month 6 Baseline and 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.Triptorelin Plasma Levels Month 1, 2, 3, 4, 5 and 6 Follicle Stimulating Hormone (FSH) Level Following GnRH Test Screening, month 3 and 6 Testosterone Level Month 0, 3 and 6 Body Mass Index (BMI) SDS Month 0, 3 and 6 Number of Girls With Inhibin B Levels < 6 pg/ml Month 0, 3 and 6 Change From Screening in Pubertal Stage (Tanner Method) at Month 6 Between screening and 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'.
Height Standard Deviation Score (SDS) Month 0, 3 and 6 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.
Uterine Length Month 0, 3 and 6
Trial Locations
- Locations (18)
Hôpital Hotel-Dieu (CHU)
🇫🇷Angers, France
Hôpital Saint-Jacques
🇫🇷Besancon, France
Medical Centre
🇫🇷Bordeaux, France
Hôpital du Bocage
🇫🇷Dijon, France
Hôpital Flaubert
🇫🇷Le Havre, France
Hôpital Jeanne de Flandre
🇫🇷Lille, France
Hôpital de la Timone Enfants
🇫🇷Marseille, France
Hôpital Debrousse
🇫🇷Lyon, France
Hôpital Archet 2
🇫🇷Nice, France
Hôpital St-Vincent de Paul
🇫🇷Paris, France
Hôpital Necker - Enfants Malades
🇫🇷Paris, France
Hôpital Trousseau
🇫🇷Paris, France
American Memorial Hospital
🇫🇷Reims, France
Hôpital Robert Debré
🇫🇷Paris, France
Hôpital Charles Nicolle
🇫🇷Rouen, France
Hôpital Hautepierre
🇫🇷Strasbourg, France
Hôpital de la Gespe
🇫🇷Tarbes, France
Hôpital des Enfants
🇫🇷Toulouse, France