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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name DECAPUB

NCTNCT00909844 (opens ClinicalTrials.gov in a new tab)Other id2-54-52014-159Other id2008-000565-39Other id2008
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
35 participants (actual)
Sponsor
Ipsen · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

France

Start
Apr 2008
Primary completion
Apr 2015
Completion
Jan 2016
First posted
29 May 2009 (estimated)
Last update posted
15 Jan 2019
Conditions
Precocious Puberty

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20082010201220142016
  1. Ph 3

    DECAPUB

    NCT00909844

    Apr 2008 to Jan 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Triptorelin (I.N.N.)Drug

Arms1

  • Experimental

    Triptorelin

Primary outcomes1

Outcomes the sponsor listed as primary.

  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)

    Registry description

    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 outcomes(12)

  1. Percentage of Patients With a Suppressed Luteinizing Hormone (LH) Response to Gonadotropin-Releasing Hormone (GnRH) Test

    Time frame · Months -6, 0 and 36

    Registry description

    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)

    Registry description

    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

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Months 12, 24, 36, 48 and Final Visit (if applicable; up to 63 months)

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)

GroupValue (percentage of patients)
Triptorelin Pamoate 11.25 mg61.8
Secondary and other outcome results(7)
Secondary outcomeNumber· Months -6, 0 and 36

Percentage of Patients With a Suppressed Luteinizing Hormone (LH) Response to Gonadotropin-Releasing Hormone (GnRH) Test

GroupValue (percentage of patients)
Triptorelin Pamoate 11.25 mg0
Secondary outcomeMean· Months -6, 0, 12, 36 and Final Visit (up to 63 months)

Levels of Oestradiol in Girls or Testosterone in Boys Both Measured by Radioimmunoassay (RIA)

GroupValue (picograms per millilitre (pg/mL))Spread
Triptorelin Pamoate 11.25 mg18.599.79
Secondary outcomeNumber· Months -6, 0 and 36

Percentage of Patients With a Suppressed Follicle Stimulating Hormone (FSH) Response to GnRH Test

GroupValue (percentage of patients)
Triptorelin Pamoate 11.25 mg0
Secondary outcomeMean· Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months)

Body Mass Index (BMI) for Chronological Age Variation

GroupValue (kilograms per metre squared (kg/m^2))Spread
Triptorelin Pamoate 11.25 mg0.430.74
Secondary outcomeMean· Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months)

BMI Standard Deviation (SD) Score for Chronological Age Variation

GroupValue (SD score)Spread
Triptorelin Pamoate 11.25 mg0.060.27
Secondary outcomeMean· Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months)

Auxological Parameters Variations: Height SD Score

GroupValue (SD score)Spread
Triptorelin Pamoate 11.25 mg0.090.14
Secondary outcomeMean· Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months)

Auxological Parameters Variations: Growth Velocity SD Score

GroupValue (SD score)Spread
Triptorelin Pamoate 11.25 mg-1.852.10

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Triptorelin Pamoate 11.25 mg11.25 mg triptorelin pamoate (prolonged release formulation) was administered via intramuscular (i.m.) injection once every 3 months from Baseline until end of the study treatment.–3 / 3516 / 35

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
Not stated
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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