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

Precocious Puberty Clinical Trial

— DECAPUB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00909844
• Other study ID #: 2-54-52014-159
• Secondary ID: 2008-000565-39
• Status: Completed
• Phase: Phase 3
• Start date: April 2008
• Est. completion date: January 2016

Study information

• Verified date: January 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Precocious Puberty
• Puberty, Precocious

Intervention

Drug:
• Triptorelin (I.N.N.)
Decapeptyl® SR 11.25mg

Locations

Country	Name	City	State
France	Hôpital Hôtel Dieu (CHU)	Angers
France	Medical Centre	Bordeaux
France	Hôpital Flaubert	Le Havre
France	Hôpital Archet II	Nice
France	Hôpital Robert Debré	Paris
France	American Memorial Hospital	Reims
France	Hôpital Charles Nicolle	Rouen
France	Hôpital Hautepierre	Strasbourg
France	Hôpital de la Gespe	Tarbes
France	Hôpital des Enfants	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)