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    Clinical Trial Results:
    A Phase II, Multicentre, Open, Prospective, Randomised, Parallel-Group, Pharmacodynamic Equivalence study on Intramuscular Versus Subcutaneous applications of Triptorelin Pamoate (Pamorelin® LA 11.25 mg) in patients with Advanced Prostate Cancer

    Summary
    EudraCT number
    2010-019632-12
    Trial protocol
    DE  
    Global end of trial date
    07 May 2012

    Results information
    Results version number
    v1(current)
    This version publication date
    04 Feb 2016
    First version publication date
    04 Feb 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    A-94-52014-178
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01257425
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Ipsen Pharma GmbH
    Sponsor organisation address
    Willy-Brandt-Straße 3, Ettlingen, Germany, D-76275
    Public contact
    Medical Director, Oncology, Ipsen, clinical.trials@ipsen.com
    Scientific contact
    Medical Director, Oncology, 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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    25 Jun 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Feb 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    07 May 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the pharmacodynamic equivalence of triptorelin pamoate (Pamorelin® LA 11.25 mg), applied either as intramuscular (IM) or subcutaneous (SC)injections, in terms of the area under the curve (AUC1-85d) for serum testosterone in patients with advanced prostate cancer.
    Protection of trial subjects
    The study and the archiving of essential documents were performed in compliance with Good Clinical Practices (GCP) and in accordance with the Declaration of Helsinki. Triptorelin pamoate 3-month formulation (Pamorelin® LA 11.25 mg) has been investigated and is approved for intramuscular application only (5, 6). However, many elderly patients with prostate cancer suffer from accompanying diseases which require anticoagulant medication, and subcutaneous injections are often preferred in anticoagulated patients.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    16 Dec 2010
    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
    Germany: 103
    Worldwide total number of subjects
    103
    EEA total number of subjects
    103
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    10
    From 65 to 84 years
    85
    85 years and over
    8

    Subject disposition

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    Recruitment
    Recruitment details
    Patients diagnosed with advanced prostate cancer (locally advanced or metastatic, histologically proven) recruited at 23 investigational sites in Germany

    Pre-assignment
    Screening details
    109 patients screened and 6 of these did not fulfil randomisation criteria therefore 103 patients were randomised to either group of treatment with triptorelin pamoate 3-month formulation applied intramuscularly or subcutaneously.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Group A: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM
    Arm description
    Pamorelin® LA 11.25 mg administered as standard IM injection (= reference group) at Day 1 and Day 85
    Arm type
    Experimental

    Investigational medicinal product name
    Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for prolonged-release suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Pamorelin® (triptorelin pamoate), 11.25 mg, intramuscular injection

    Arm title
    Group B: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC
    Arm description
    Pamorelin® LA 11.25 mg administered as SC injection at Day 1 and Day 85
    Arm type
    Experimental

    Investigational medicinal product name
    Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for prolonged-release suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Pamorelin® (triptorelin pamoate), 11.25 mg, subcutaneous injection

    Number of subjects in period 1
    Group A: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM Group B: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC
    Started
    51
    52
    Completed
    45
    46
    Not completed
    6
    6
         Death
    -
    1
         Protocol deviation
    1
    1
         Lack of efficacy
    3
    3
         Adverse event, non-fatal
    1
    1
         Consent withdrawn by subject
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group A: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM
    Reporting group description
    Pamorelin® LA 11.25 mg administered as standard IM injection (= reference group) at Day 1 and Day 85

    Reporting group title
    Group B: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC
    Reporting group description
    Pamorelin® LA 11.25 mg administered as SC injection at Day 1 and Day 85

    Reporting group values
    Group A: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM Group B: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC Total
    Number of subjects
    51 52 103
    Age categorical
    Units: Subjects
        50 to < 60
    2 2 4
        60 to < 70
    11 10 21
        70 to < 80
    31 30 61
        80 to < 90
    7 10 17
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    73.3 ± 7 73.4 ± 6.7 -
    Gender categorical
    Units: Subjects
        Female
    0 0 0
        Male
    51 52 103
    Race
    Units: Subjects
        Caucasian
    51 52 103
    Karnofsky index (%)
    Karnofsky index is a measure of performance status to quantify cancer patients' general well-being and activities of daily life. Karnofsky scores run from 100% (perfect health) to 0% (death). Analysed from Intent-to-treat (ITT) population comprised of 103 patients (SC:52 patients and IM:51 patients).
    Units: Subjects
        100%
    27 21 48
        90%
    12 18 30
        80%
    12 13 25
    Prostate specific antigen (PSA) level
    Analysed from Intent-to-treat (ITT) population with one missing value in the IM group.
    Units: ng/mL
        arithmetic mean (standard deviation)
    97.2 ± 368 47.1 ± 174.9 -
    Testosterone serum level
    Analysed from Intent-to-treat (ITT) population comprised of 103 patients (SC:52 patients and IM:51 patients).
    Units: ng/mL
        arithmetic mean (standard deviation)
    3.12 ± 1.36 3.23 ± 1.28 -
    Tumour-related pain
    Analysed from modified ITT population comprised of 98 patients (SC: 49 and IM: 49 patients). Tumour-related pain at baseline was rated by the patient by means of a 10-cm visual analogue scale (VAS), ranging from 0 (no pain) to 10 (maximum pain).
    Units: cm
        arithmetic mean (standard deviation)
    0.37 ± 0.99 0.25 ± 0.58 -

    End points

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    End points reporting groups
    Reporting group title
    Group A: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM
    Reporting group description
    Pamorelin® LA 11.25 mg administered as standard IM injection (= reference group) at Day 1 and Day 85

    Reporting group title
    Group B: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC
    Reporting group description
    Pamorelin® LA 11.25 mg administered as SC injection at Day 1 and Day 85

    Primary: Area under the curve of testosterone serum concentration (AUC1-85d)

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    End point title
    Area under the curve of testosterone serum concentration (AUC1-85d)
    End point description
    Area under the curve (AUC) calculated from serum testosterone concentration taken at intervals between the first administration (Day 1) of the study drug and Day 85 after dosing. From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods. This value was log-transformed to more closely meet the assumption of the statistical method.
    End point type
    Primary
    End point timeframe
    Between Day 1 and Day 85
    End point values
    Group A: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM Group B: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC
    Number of subjects analysed
    51
    52
    Units: log(ng*day/mL)
        arithmetic mean (standard deviation)
    4.23 ± 0.497
    4.241 ± 0.396
    Statistical analysis title
    Summary of AUC1-85d
    Comparison groups
    Group B: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC v Group A: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    Method
    Parameter type
    Ratio of AUC values
    Point estimate
    0.977
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.88
         upper limit
    1.08

    Secondary: Area under the curve of testosterone serum concentration (AUC1-169d)

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    End point title
    Area under the curve of testosterone serum concentration (AUC1-169d)
    End point description
    Area under the curve calculated from serum testosterone concentration taken at intervals between the first administration (Day 1) of the study drug and Day 169 after dosing. From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods. This value was log-transformed to more closely meet the assumption of the statistical method.
    End point type
    Secondary
    End point timeframe
    Between Day 1 and Day 169
    End point values
    Group A: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM Group B: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC
    Number of subjects analysed
    51
    52
    Units: log(ng*day/mL)
        arithmetic mean (standard deviation)
    4.524 ± 0.558
    4.486 ± 0.422
    Statistical analysis title
    Summary of AUC1-169d
    Comparison groups
    Group A: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM v Group B: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    Method
    Parameter type
    Ratio of AUC values
    Point estimate
    0.932
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.82
         upper limit
    1.06

    Secondary: Area under the curve of testosterone serum concentration (AUC85-169d)

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    End point title
    Area under the curve of testosterone serum concentration (AUC85-169d)
    End point description
    Area under the curve calculated from serum testosterone concentration taken at intervals between Day 85 and Day 169 after dosing. From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods. This value was log-transformed to more closely meet the assumption of the statistical method. 95 patients (IM: 47 patients, SC: 48 patients) received a second injection of the study drug.
    End point type
    Secondary
    End point timeframe
    Between Day 85 and Day 169
    End point values
    Group A: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM Group B: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC
    Number of subjects analysed
    47
    48
    Units: log(ng*day/mL)
        arithmetic mean (standard deviation)
    2.884 ± 0.381
    2.799 ± 0.451
    Statistical analysis title
    Summary of AUC85-169d
    Comparison groups
    Group A: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM v Group B: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    Method
    Parameter type
    Ratio of AUC values
    Point estimate
    0.91
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.81
         upper limit
    1.02

    Secondary: Maximum concentration of serum testosterone (Cmax) - Raw Data

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    End point title
    Maximum concentration of serum testosterone (Cmax) - Raw Data
    End point description
    Cmax was assessed as the maximum testosterone serum concentration between the first administration of the study drug and Day 169. Analysed for intent-to-treat (ITT) population comprised of 103 patients (IM: 51 and SC: 52 patients).
    End point type
    Secondary
    End point timeframe
    Between Day 1 and Day 169
    End point values
    Group A: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM Group B: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC
    Number of subjects analysed
    51
    52
    Units: ng/mL
        arithmetic mean (standard deviation)
    5.495 ± 2.348
    5.738 ± 2.333
    No statistical analyses for this end point

    Secondary: Maximum concentration of serum testosterone (Cmax) - Log-transformed Data

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    End point title
    Maximum concentration of serum testosterone (Cmax) - Log-transformed Data
    End point description
    Cmax was assessed as the maximum testosterone serum concentration between the first administration of the study drug and Day 169. Analysed for intent-to-treat (ITT) population comprised of 103 patients (IM: 51 and SC: 52 patients).
    End point type
    Secondary
    End point timeframe
    Between Day 1 and Day 169
    End point values
    Group A: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM Group B: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC
    Number of subjects analysed
    51
    52
    Units: log(ng/mL)
        arithmetic mean (standard deviation)
    1.62 ± 0.415
    1.665 ± 0.423
    Statistical analysis title
    Summary of Cmax Log-transformed Data
    Comparison groups
    Group A: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM v Group B: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.8516
    Method
    ANCOVA
    Parameter type
    Mean difference (net)
    Point estimate
    0.01
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.09
         upper limit
    0.11

    Secondary: Time to Castration [Tcast] - Testosterone Level Less Than or Equal to 0.5 ng/mL

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    End point title
    Time to Castration [Tcast] - Testosterone Level Less Than or Equal to 0.5 ng/mL
    End point description
    tcast is the number of days between day of first administration of the study drug and the day the testosterone level reaches the limit of castration defined as testosterone level less than or equal to 0.5 ng/mL for the first time. Analysis of tcast was based on the Kaplan-Meier estimator. Analysed for intent-to-treat (ITT) population comprised of 103 patients (IM: 51 and SC: 52 patients).
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    Group A: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM Group B: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC
    Number of subjects analysed
    51
    52
    Units: days
        median (confidence interval 95%)
    22 (22 to 23)
    22 (22 to 23)
    Statistical analysis title
    Summary of [Tcast] Testosterone Level ≤ 0.5 ng/mL
    Comparison groups
    Group A: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM v Group B: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.98
    Method
    Logrank
    Confidence interval

    Secondary: Time to Castration [Tcast] - Testosterone Level Less Than 0.5 ng/mL

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    End point title
    Time to Castration [Tcast] - Testosterone Level Less Than 0.5 ng/mL
    End point description
    tcast is the number of days between day of first administration of the study drug and the day the testosterone level reaches the limit of castration defined as testosterone level less than 0.5 ng/mL for the first time. Analysis of tcast was based on the Kaplan-Meier estimator. Analysed for intent-to-treat (ITT) population comprised of 103 patients (IM: 51 and SC: 52 patients).
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    Group A: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM Group B: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC
    Number of subjects analysed
    51
    52
    Units: days
        median (confidence interval 95%)
    22 (22 to 23)
    22 (22 to 23)
    Statistical analysis title
    Summary of [Tcast] Testosterone Level < 0.5 ng/mL
    Comparison groups
    Group A: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM v Group B: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.84
    Method
    Logrank
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Day 169
    Adverse event reporting additional description
    All AEs which occurred from the time that the subject gave informed consent to the end of the study (visit D169) were considered for analysis
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    Group A: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM
    Reporting group description
    -

    Reporting group title
    Group B: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC
    Reporting group description
    -

    Serious adverse events
    Group A: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM Group B: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 51 (13.73%)
    11 / 52 (21.15%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Subdural Haematoma
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Coronary Artery Disease
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary Artery Stenosis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina Pectoris
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon Cancer
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphoma
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastasis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Plasmacytoma
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Failure
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular Accident
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient Ischaemic Attack
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Inguinal Hernia, Obstructive
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal Hernia
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical Hernia
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Bladder outlet obstruction
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyuria
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Failure
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Failure Acute
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral Stenosis
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Retention
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Urosepsis
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mediastinitis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal abscess
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Group A: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM Group B: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 51 (49.02%)
    32 / 52 (61.54%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    14 / 51 (27.45%)
    15 / 52 (28.85%)
         occurrences all number
    14
    15
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 51 (5.88%)
    0 / 52 (0.00%)
         occurrences all number
    3
    0
    Psychiatric disorders
    Sleep disorder
         subjects affected / exposed
    0 / 51 (0.00%)
    3 / 52 (5.77%)
         occurrences all number
    0
    3
    Renal and urinary disorders
    Nocturia
         subjects affected / exposed
    0 / 51 (0.00%)
    3 / 52 (5.77%)
         occurrences all number
    0
    3
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    4 / 51 (7.84%)
    5 / 52 (9.62%)
         occurrences all number
    4
    5
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 51 (1.96%)
    3 / 52 (5.77%)
         occurrences all number
    1
    5
    Infections and infestations
    Urinary Tract Infection
         subjects affected / exposed
    3 / 51 (5.88%)
    3 / 52 (5.77%)
         occurrences all number
    4
    4

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Aug 2010
    The first amendment, dated 16 August 2010, was substantial and aimed to change the wording (linguistic change) in definition of pharmacodynamic equivalence between the two modes of administration and to add a further exclusion criterion (to exclude participation in another clinical trial within the last 30 days or simultaneous participation in another clinical trial). As this amendment was in place prior to enrolment of the first patient into the study, it did not affect the conduct of the study.

    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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