Effects of Triptorelin Pamoate in Children With Precocious Puberty - Follow up Study (DECAPUB)

Follow-up of the Phase III, Multicentre, Non Comparative, One Single Group, Open Study to Assess the Long-term Efficacy and Tolerability of Pamoate of Triptorelin 11.25 mg in Children With Precocious Puberty

The purpose of the protocol is to assess the efficacy of triptorelin 11.25 mg with respect to the proportion of children who maintain a regression or stabilisation of sexual maturity until the end of the study.

Study Overview

• Status: Completed
• Conditions: Precocious Puberty
• Intervention / Treatment: Drug: Triptorelin (I.N.N.)

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Angers, France, 49033
    • Hôpital Hôtel Dieu (CHU)
  • Bordeaux, France, 33000
    • Medical Centre
  • Le Havre, France, 76083
    • Hôpital Flaubert
  • Nice, France, 06202
    • Hôpital ARCHET II
  • Paris, France, 75019
    • Hopital Robert Debre
  • Reims, France, 51092
    • American Memorial Hospital
  • Rouen, France, 76031
    • Hôpital Charles Nicolle
  • Strasbourg, France, 67100
    • Hôpital Hautepierre
  • Tarbes, France, 65013
    • Hôpital de la Gespe
  • Toulouse, France, 31026
    • Hopital des Enfants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The child must have completed study 2-54-52014-143
• The child must have an effective response to 2 injections of triptorelin 11.25 mg according to investigator's evaluation with no significant treatment side effects

Exclusion Criteria:

• The patient has a known hypersensitivity to any of the test materials or related compounds
• The patient is unable or unwilling to comply fully with the protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Triptorelin	Drug: Triptorelin (I.N.N.); Decapeptyl® SR 11.25mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Children With a Stabilisation or Regression of Tanner Pubertal Stage at the End of the Study (Final Visit), Compared to Pretreatment (Month -6) and Baseline (Month 0)	The primary objective was to assess efficacy of triptorelin pamoate 11.25 mg with respect to percentage of children maintaining a regression or stabilisation of sexual maturity (based on Tanner breast [girls] or genital [boys] pubertal stage) until end of study. Study treatment lasted until end of the therapeutic period; visits for Months 36 and 48 were optional since a child may have already finished the study at a prior visit. The Final Visit only occurred if the child did not end the study by a complete visit such as at Months 24, 36 or 48. Results are presented only for percentage of girls with regression or stabilisation of Tanner breast pubertal stage (n=34). Since only one boy was included in the study, results for this outcome measure were listed only and no statistical analysis was performed. Please also note additional post-hoc analysis for regression or stabilisation of Tanner breast pubertal stage which applied the variable Last Visit on Treatment instead of Final Visit.	Months 12, 24, 36, 48 and Final Visit (if applicable; up to 63 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients With a Suppressed Luteinizing Hormone (LH) Response to Gonadotropin-Releasing Hormone (GnRH) Test	A suppressed LH response to the GnRH test was defined as a stimulated peak of LH ≤3 international units per litre (IU/L). Percentage of patients who had a suppressed LH response to the GnRH test is reported. It should be noted that almost no hormonal data was collected after Baseline; all data analysed is presented.	Months -6, 0 and 36
Levels of Oestradiol in Girls or Testosterone in Boys Both Measured by Radioimmunoassay (RIA)	Mean levels of oestradiol in girls or testosterone in boys are reported. It should be noted that almost no hormonal data was collected after Baseline; all data analysed is presented.	Months -6, 0, 12, 36 and Final Visit (up to 63 months)
Percentage of Patients With a Suppressed Follicle Stimulating Hormone (FSH) Response to GnRH Test	A suppressed FSH response to the GnRH test was defined as a stimulated peak of FSH ≤3 IU/L. Percentage of patients who had a suppressed FSH response to the GnRH test is reported. It should be noted that almost no hormonal data was collected after Baseline; all data analysed is presented.	Months -6, 0 and 36
Body Mass Index (BMI) for Chronological Age Variation	Mean changes of BMI from Pretreatment and from Baseline are reported. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.	Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months)
BMI Standard Deviation (SD) Score for Chronological Age Variation	Mean changes of BMI SD score from Pretreatment and from Baseline are reported. SD score is a standard term used in growth studies and represents standard deviations calculated as the patient value minus the mean divided by the SD. SD scores vary depending on the age and sex of the child. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.	Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months)
Auxological Parameters Variations: Height SD Score	Mean changes of height SD score from Pretreatment and from Baseline are reported. SD score is a standard term used in growth studies and represents standard deviations calculated as the patient value minus the mean divided by the SD. SD scores vary depending on the age and sex of the child. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.	Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months)
Auxological Parameters Variations: Growth Velocity SD Score	Mean changes of growth velocity SD score from Pretreatment and from Baseline are reported. SD score is a standard term used in growth studies and represents standard deviations calculated as the patient value minus the mean divided by the SD. SD scores vary depending on the age and sex of the child. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.	Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months)
Auxological Parameters Variations: Weight Variation	Mean changes of weight from Pretreatment and from Baseline are reported. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.	Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months)
Predicted Adult Height SD Score	Mean change of predicted adult height SD score from Pretreatment and from Baseline are reported. SD score is a standard term used in growth studies and represents standard deviations calculated as the patient value minus the mean divided by the SD. SD scores vary depending on the age and sex of the child. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented. Also note that data for this endpoint was analysed for girls only.	Months -6, 0, 12 and Final Visit (up to 63 months)
Bone Age Maturation	Mean change in difference between bone age and chronological age from Pretreatment and from Baseline are reported. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.	Months -6, 0 and Final Visit (up to 63 months)
Percentage of Girls With a Uterine Length < 36 Millimetres (mm)	Percentage of girls who had a uterine length < 36 mm are reported. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.	Months -6, 0, 12, 24, 36 and Final Visit (up to 63 months)
Percentage of Children With a Stabilisation or Regression of Tanner Pubic Hair Pubertal Stage at the End of the Study (Final Visit), Compared to Pretreatment (Month -6) and Baseline (Month 0)	Pubic hair was measured by the Tanner method on a scale of 1 to 6. A low grade (i.e. 1) corresponds to a pre-pubertal stage and a high grade (i.e. 5 or 6) to an adult stage. Percentage of patients who had stabilisation or regression (no change in grade or a reduced grade) of Tanner pubic hair pubertal stage is reported. Study treatment was to last until the end of the therapeutic period; visits for Months 36 and 48 were optional because if the girl was already 11 and the boy already 13, they would have finished the study at a prior visit. The Final Visit was to occur only if the child did not end the study by a complete visit such as at Months 24, 36 or 48. Please also note the additional post-hoc analysis for percentage of children with a stabilisation or regression of Tanner pubic hair pubertal stage which applied the variable Last Visit on Treatment instead of Final Visit.	Months 12, 24, 36, 48 and Final Visit (if applicable; up to 63 months)

Collaborators and Investigators

• Sponsor: Ipsen

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (ACTUAL): April 1, 2015
• Study Completion (ACTUAL): January 1, 2016

Study Registration Dates

• First Submitted: May 28, 2009
• First Submitted That Met QC Criteria: May 28, 2009
• First Posted (ESTIMATE): May 29, 2009

Study Record Updates

• Last Update Posted (ACTUAL): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 11, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Gonadal Disorders; Puberty, Precocious; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Luteolytic Agents; Triptorelin Pamoate
• Other Study ID Numbers: 2-54-52014-159; 2008-000565-39 (EUDRACT_NUMBER)