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

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Precocious Puberty	Drug: Triptorelin (I.N.N.)	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	35 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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
Study Start Date :	April 2008
Actual Primary Completion Date :	April 2015
Actual Study Completion Date :	January 2016

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Triptorelin	Drug: Triptorelin (I.N.N.); Decapeptyl® SR 11.25mg

Outcome Measures

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Primary Outcome Measures :

1. 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) [ Time Frame: Months 12, 24, 36, 48 and Final Visit (if applicable; up to 63 months) ]
   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.

Secondary Outcome Measures :

1. Percentage of Patients With a Suppressed Luteinizing Hormone (LH) Response to Gonadotropin-Releasing Hormone (GnRH) Test [ Time Frame: Months -6, 0 and 36 ]
   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.
2. Levels of Oestradiol in Girls or Testosterone in Boys Both Measured by Radioimmunoassay (RIA) [ Time Frame: Months -6, 0, 12, 36 and Final Visit (up to 63 months) ]
   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.
3. Percentage of Patients With a Suppressed Follicle Stimulating Hormone (FSH) Response to GnRH Test [ Time Frame: Months -6, 0 and 36 ]
   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.
4. Body Mass Index (BMI) for Chronological Age Variation [ Time Frame: Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months) ]
   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.
5. BMI Standard Deviation (SD) Score for Chronological Age Variation [ Time Frame: Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months) ]
   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.
6. Auxological Parameters Variations: Height SD Score [ Time Frame: Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months) ]
   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.
7. Auxological Parameters Variations: Growth Velocity SD Score [ Time Frame: Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months) ]
   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.
8. Auxological Parameters Variations: Weight Variation [ Time Frame: Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months) ]
   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.
9. Predicted Adult Height SD Score [ Time Frame: Months -6, 0, 12 and Final Visit (up to 63 months) ]
   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.
10. Bone Age Maturation [ Time Frame: Months -6, 0 and Final Visit (up to 63 months) ]
    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.
11. Percentage of Girls With a Uterine Length < 36 Millimetres (mm) [ Time Frame: Months -6, 0, 12, 24, 36 and Final Visit (up to 63 months) ]
    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.
12. 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) [ Time Frame: Months 12, 24, 36, 48 and Final Visit (if applicable; up to 63 months) ]
    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.

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

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

Sponsors and Collaborators

Ipsen

Investigators

Study Director:	Olivier GATTOLLIAT, MD	Ipsen

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Ipsen
ClinicalTrials.gov Identifier:	NCT00909844 History of Changes
Other Study ID Numbers:	2-54-52014-159; 2008-000565-39 ( EudraCT Number )
First Posted:	May 29, 2009
Results First Posted:	May 1, 2017
Last Update Posted:	May 1, 2017
Last Verified:	March 2017

Additional relevant MeSH terms:

Puberty, Precocious; Gonadal Disorders; Endocrine System Diseases; Triptorelin Pamoate; Luteolytic Agents; Contraceptive Agents, Female	Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Antineoplastic Agents, Hormonal; Antineoplastic Agents