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    Clinical Trial Results:
    Phase III, multicentre, non comparative, open and single stage study to assess the efficacy and safety of pamoate of triptorelin 11.25 mg in children with precocious puberty.

    Summary
    EudraCT number
    		 2005-005644-11
    Trial protocol
    		 FR  
    Global end of trial date
    27 Oct 2010

    Results information
    Results version number
    		 v2(current)
    This version publication date
    05 Sep 2024
    First version publication date
    12 Aug 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Data validation

    Trial information

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    Trial identification
    Sponsor protocol code
    2-54-52014-143
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00564850
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ipsen
    Sponsor organisation address
    65 Quai Georges Gorse, Boulogne-Billancourt Cedex, France, 92650
    Public contact
    Medical Director, Endocrinology, Ipsen, clinical.trials@ipsen.com
    Scientific contact
    Medical Director, Endocrinology, Ipsen, clinical.trials@ipsen.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    24 Nov 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Oct 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Oct 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of Triptorelin 11.25 mg pamoate with respect to the proportion of children with suppressed Luteinizing Hormone (LH) response (LH < or =3 UI/l) to Gonadotropin Releasing Hormone (GnRH) test performed 3 months (M3) after injection with Triptorelin 11.25 mg.
    Protection of trial subjects
    This clinical study was designed and implemented and reported in accordance with the International Conference on Harmonisation (ICH) Harmonized Tripartite Guidelines for Good Clinical Practice (GCP), with applicable local regulations (including European Directive 2001/20/EC, US Code of Federal Regulations Title 21, and Japanese Ministry of Health, Labor, and Welfare), and with the ethical principles laid down in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Oct 2007
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 37
    Worldwide total number of subjects
    37
    EEA total number of subjects
    37
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    37
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 62 participants were screened, of which 37 met the study's entry criteria and received at least one dose of investigational medicinal product. 25 participants failed screening. Participants were recruited from October 2007 at 18 Hospital clinics across France.

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 62 [1]
    Number of subjects completed
    		 37

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Physician decision: 2
    Reason: Number of subjects
    		 Three Criteria Failed: 3
    Reason: Number of subjects
    		 Two Criteria Failed: 7
    Reason: Number of subjects
    		 One Criterion Failed: 13
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: World-wide subject number (N=62) includes screen failure subjects and pre-assignment period does not include screen failure subjects.
    Period 1
    Period 1 title
    Treatment phase (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Triptorelin pamoate 11.25 mg
    Arm description
    		 Triptorelin pamoate 11.25 mg two intramuscular injections at baseline and month 3
    Arm type
    		 Experimental

    Investigational medicinal product name
    Decapeptyl PR
    Investigational medicinal product code
    Other name
    triptorelin pamoate
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    11.25 mg two intramuscular injections at baseline and month 3

    Number of subjects in period 1
    		Triptorelin pamoate 11.25 mg
    Started
    37
    Completed
    35
    Not completed
    2
         Protocol deviation
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment phase
    Reporting group description
    		 -

    Reporting group values
    		 Treatment phase Total
    Number of subjects
    		 37 37
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 37 37
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 8.2 ( 1.1 ) -
    Gender categorical
    Units: Subjects
        Female
    		 36 36
        Male
    		 1 1
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 32.76 ( 7.36 ) -

    End points

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    End points reporting groups
    Reporting group title
    Triptorelin pamoate 11.25 mg
    Reporting group description
    		 Triptorelin pamoate 11.25 mg two intramuscular injections at baseline and month 3

    Primary: Number of Participants With a GnRH-stimulated LH Level ≤3 IU/L

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    End point title
    		 Number of Participants With a GnRH-stimulated LH Level ≤3 IU/L [1]
    End point description
    Analyses performed on: Intention to Treat (ITT): All patients having received ≥1 injection. Any subject with missing data is considered a non-responder. Modified ITT (mITT): All ITT patients with ≥ Month 3 post-baseline assessment of primary efficacy criterion. Per Protocol (PP): All mITT patients without major protocol deviations.
    End point type
    Primary
    End point timeframe
    3 months after the first injection of triptorelin pamoate 11.25 mg
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis for the primary endpoint was provided with 95% confidence interval to give an indication of the magnitude for the population mean.
    End point values
    		 Triptorelin pamoate 11.25 mg
    Number of subjects analysed
    37
    Units: Participants
        Yes [ITT (n=37)]
    31
        No [ITT (n=37)]
    6
        Yes [mITT (n=34)]
    31
        No [mITT (n=34)]
    3
        Yes [PP (n=32)]
    30
        No [PP (n=32)]
    2
    No statistical analyses for this end point

    Secondary: Number of Participants Whose Intravenous (i.v.) GnRH-stimulated LH Response Was ≤3 IU/L

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    End point title
    		 Number of Participants Whose Intravenous (i.v.) GnRH-stimulated LH Response Was ≤3 IU/L
    End point description
    Analysis was performed on Intention to Treat population (ITT) defined as all participants having received at least one injection of 11.25 mg triptorelin pamoate. "n" indicates the number of patients who had an assessment at the visit
    End point type
    Secondary
    End point timeframe
    Month 6
    End point values
    		 Triptorelin pamoate 11.25 mg
    Number of subjects analysed
    37
    Units: Participants
        Yes (n=37)
    32
        No (n=37)
    5
    No statistical analyses for this end point

    Secondary: Follicle Stimulating Hormone (FSH) Level Following GnRH Test

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    End point title
    		 Follicle Stimulating Hormone (FSH) Level Following GnRH Test
    End point description
    Analysis was performed on the ITT population. 3 participants and 2 participants had missing data at month 3 and month 6 respectively.
    End point type
    Secondary
    End point timeframe
    Screening, month 3 and 6
    End point values
    		 Triptorelin pamoate 11.25 mg
    Number of subjects analysed
    37
    Units: IU/L
    arithmetic mean (standard deviation)
        Screening (n=37)
    11.84 ( 3.23 )
        Month 3 (n=34)
    2.26 ( 2.5 )
        Month 6 (n=35)
    2.34 ( 1.65 )
    No statistical analyses for this end point

    Secondary: Basal FSH Level

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    End point title
    		 Basal FSH Level
    End point description
    Analysis was performed on the ITT population. 2 participants had missing data at month 1, 3, 4 and 6. 1 and 3 participants had missing data at month 2 and month 5 respectively.
    End point type
    Secondary
    End point timeframe
    Month 0, 1, 2, 3, 4, 5, and 6
    End point values
    		 Triptorelin pamoate 11.25 mg
    Number of subjects analysed
    37
    Units: IU/L
    arithmetic mean (standard deviation)
        Month 0 (screening, n=37)
    4.13 ( 2.65 )
        Month 1 (n=35)
    0.67 ( 0.53 )
        Month 2 (n=36)
    1.07 ( 0.82 )
        Month 3 (n=35)
    1.11 ( 0.73 )
        Month 4 (n=35)
    0.78 ( 0.39 )
        Month 5 (n=34)
    1.41 ( 2.09 )
        Month 6 (n=35)
    1.36 ( 1.24 )
    No statistical analyses for this end point

    Secondary: Basal LH Level

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    End point title
    		 Basal LH Level
    End point description
    Analysis was performed on ITT population. 2 participants had missing data at month 1, 3, 4 and 6. 1 and 3 participants had missing data at month 2 and month 5 respectively.
    End point type
    Secondary
    End point timeframe
    Month 0, 1, 2, 3, 4, 5 and 6
    End point values
    		 Triptorelin pamoate 11.25 mg
    Number of subjects analysed
    37
    Units: IU/L
    arithmetic mean (standard deviation)
        Month 0 (screening, n=37)
    1.49 ( 1.78 )
        Month 1 (n=35)
    0.42 ( 0.22 )
        Month 2 (n=36)
    0.42 ( 0.31 )
        Month 3 (n=35
    0.43 ( 0.27 )
        Month 4 (n=35)
    0.43 ( 0.23 )
        Month 5 (n=34)
    0.48 ( 0.7 )
        Month 6 (n=35)
    0.44 ( 0.42 )
    No statistical analyses for this end point

    Secondary: Number of Girls With Oestradiol Levels ≤ 20 pg/ml

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    End point title
    		 Number of Girls With Oestradiol Levels ≤ 20 pg/ml
    End point description
    Analysis was performed on female patients in the ITT population. 2 participants had missing data at month 1, 3, 4 and 6. 1 participant and 3 participants had missing data at month 2 and 5 respectively.
    End point type
    Secondary
    End point timeframe
    Month 0, 1, 2, 3, 4, 5 and 6
    End point values
    		 Triptorelin pamoate 11.25 mg
    Number of subjects analysed
    36
    Units: Participants
        Yes - month 0 (n=36)
    22
        No - month 0 (n=36)
    14
        Yes - month 1 (n=34)
    34
        No - month 1 (n=34)
    0
        Yes - month 2 (n=35)
    34
        No - month 2 (n=35)
    1
        Yes - month 3 (n=34)
    33
        No - month 3 (n=34)
    1
        Yes - month 4 (n=34)
    34
        No - month 4 (n=34)
    0
        Yes - month 5 (n=33)
    33
        No - month 5 (n=33)
    0
        Yes - month 6 (n=34)
    33
        No - month 6 (n=34)
    1
    No statistical analyses for this end point

    Secondary: Testosterone Level

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    End point title
    		 Testosterone Level
    End point description
    Testosterone level from the male patient in the ITT population.
    End point type
    Secondary
    End point timeframe
    Month 0, 3 and 6
    End point values
    		 Triptorelin pamoate 11.25 mg
    Number of subjects analysed
    1
    Units: ng/ml
    number (not applicable)
        Month 0 (screening)
    2
        Month 3
    0.12
        Month 6
    0.16
    No statistical analyses for this end point

    Secondary: Number of Girls With Inhibin B Levels < 6 pg/ml

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    End point title
    		 Number of Girls With Inhibin B Levels < 6 pg/ml
    End point description
    Analysis was performed on female patients in the ITT population. 2 participants had missing data at month 3 and month 6.
    End point type
    Secondary
    End point timeframe
    Month 0, 3 and 6
    End point values
    		 Triptorelin pamoate 11.25 mg
    Number of subjects analysed
    36
    Units: Participants
        Yes - month 0 (screening, n=36)
    18
        No - month 0 (screening, n=36)
    18
        Yes - month 3 (n=34)
    33
        No - month 3 (n=34)
    1
        Yes - month 6 (n=34)
    32
        No - month 6 (n=34)
    2
    No statistical analyses for this end point

    Secondary: Change From Screening in Pubertal Stage (Tanner Method) at Month 6

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    End point title
    		 Change From Screening in Pubertal Stage (Tanner Method) at Month 6
    End point description
    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'. Analysis was performed on the ITT population. 2 participants had missing data for pubic hair stage and breast stage.
    End point type
    Secondary
    End point timeframe
    Between screening and month 6
    End point values
    		 Triptorelin pamoate 11.25 mg
    Number of subjects analysed
    37
    Units: Participants
        Pubic hair stage stabilised or reduced (n=35)
    30
        Pubic hair stage increased (n=35)
    5
        Breast stage stabilised or reduced (n=34)
    32
        Breast stage increased (n=34)
    2
        Penis stage stabilised or reduced (n=1)
    1
        Penis stage increased (n=1)
    0
    No statistical analyses for this end point

    Secondary: Height Standard Deviation Score (SDS)

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    End point title
    		 Height Standard Deviation Score (SDS)
    End point description
    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. Analysis was performed on the ITT population. 2 participants had missing data at month 6.
    End point type
    Secondary
    End point timeframe
    Month 0, 3 and 6
    End point values
    		 Triptorelin pamoate 11.25 mg
    Number of subjects analysed
    37
    Units: SD score
    arithmetic mean (standard deviation)
        Month 0 (baseline, n=37)
    1.25 ( 1.14 )
        Month 3 (n=37)
    1.32 ( 1.16 )
        Month 6 (n=35)
    1.32 ( 1.16 )
    No statistical analyses for this end point

    Secondary: Body Mass Index (BMI) SDS

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    End point title
    		 Body Mass Index (BMI) SDS
    End point description
    Analysis was performed on the ITT population. 1 and 2 participants had missing data at month 0 and month 6 respectively.
    End point type
    Secondary
    End point timeframe
    Month 0, 3 and 6
    End point values
    		 Triptorelin pamoate 11.25 mg
    Number of subjects analysed
    37
    Units: SD score
    arithmetic mean (standard deviation)
        Month 0 (baseline, n=36)
    0.58 ( 0.85 )
        Month 3 (n=37)
    0.64 ( 0.89 )
        Month 6 (n=35)
    0.6 ( 0.78 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Growth Velocity (GV) SDS at Month 6

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    End point title
    		 Change From Baseline in Growth Velocity (GV) SDS at Month 6
    End point description
    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. Analysis was performed on the ITT population. If GV at screening was missing, the value was derived from data recorded between 5 to 19 months ago otherwise GV at screening was considered missing. 9 participants had missing data.
    End point type
    Secondary
    End point timeframe
    Baseline and month 6
    End point values
    		 Triptorelin pamoate 11.25 mg
    Number of subjects analysed
    37
    Units: SD score
    arithmetic mean (standard deviation)
        Change From Baseline in GV SDS at Month 6
    -1.95 ( 2.07 )
    No statistical analyses for this end point

    Secondary: Difference Between Bone Age and Chronological Age

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    End point title
    		 Difference Between Bone Age and Chronological Age
    End point description
    Bone age was defined according to Greulich and Pyle method. Chronological age was calculated using the date of birth. Analysis was performed on the ITT population. 33 participants were assessed. 4 participants had missing data at month 6.
    End point type
    Secondary
    End point timeframe
    Month 0 and 6
    End point values
    		 Triptorelin pamoate 11.25 mg
    Number of subjects analysed
    37
    Units: Years
    arithmetic mean (standard deviation)
        Month 0 (screening, n=37)
    2.09 ( 0.91 )
        Month 6 (n=33)
    2.02 ( 0.88 )
    No statistical analyses for this end point

    Secondary: Uterine Length

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    End point title
    		 Uterine Length
    End point description
    Analysis was performed on female patients in the ITT population. 2 participants had missing data at month 3 and 6.
    End point type
    Secondary
    End point timeframe
    Month 0, 3 and 6
    End point values
    		 Triptorelin pamoate 11.25 mg
    Number of subjects analysed
    36
    Units: mm
    arithmetic mean (standard deviation)
        Month 0 (screening, n=35)
    37.6 ( 10.6 )
        Month 3 (n=34)
    37.4 ( 8.2 )
        Month 6 (n=34)
    36.8 ( 6.9 )
    No statistical analyses for this end point

    Secondary: Triptorelin Plasma Levels

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    End point title
    		 Triptorelin Plasma Levels
    End point description
    Analysis was performed on the Pharmacokinetics (PK) Valid population defined as all participants who received at least one injection of 11.25 mg triptorelin pamoate and had at least one PK assessment. 2 participants had data missing at month 1,3 and 6. 1, 3 and 4 participants had data missing at month 2, 4 and 5 respectively.
    End point type
    Secondary
    End point timeframe
    Month 1, 2, 3, 4, 5 and 6
    End point values
    		 Triptorelin pamoate 11.25 mg
    Number of subjects analysed
    37
    Units: ng/mL
    arithmetic mean (standard deviation)
        Month 1 (n=35)
    0.187 ( 0.115 )
        Month 2 (n=36)
    0.048 ( 0.023 )
        Month 3 (n=35)
    0.034 ( 0.018 )
        Month 4 (n=34)
    0.201 ( 0.120 )
        Month 5 (n=33)
    0.045 ( 0.023 )
        Month 6 (n=35)
    0.03 ( 0.017 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to month 6
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    Triptorelin pamoate 11.25 mg
    Reporting group description
    		 -

    Serious adverse events
    		 Triptorelin pamoate 11.25 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 37 (2.70%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Foot fracture
         subjects affected / exposed
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Triptorelin pamoate 11.25 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 37 (21.62%)
    Vascular disorders
    Hot Flush
         subjects affected / exposed
    2 / 37 (5.41%)
         occurrences all number
    2
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    2 / 37 (5.41%)
         occurrences all number
    2
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    4 / 37 (10.81%)
         occurrences all number
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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