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    Clinical Trial Results:
    A randomised, double-blind, parallel groups, placebo-controlled, multi-centre study assessing the effects of a selective oxytocin antagonist (barusiban) and a mixed oxytocin antagonist – vasopressin V1a antagonist (atosiban) administered intravenously on luteal phase uterine contractions in oocyte donors supplemented with vaginal progesterone

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines
    Summary
    EudraCT number
    2007-003158-27
    Trial protocol
    BE   PL   ES  
    Global end of trial date
    11 Sep 2008

    Results information
    Results version number
    v1(current)
    This version publication date
    06 Jan 2017
    First version publication date
    06 Jan 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    FE 200440 CS09
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00587327
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Ferring Pharmaceuticals A/S
    Sponsor organisation address
    Kay Fiskers Plads 11, Copenhagen S, Denmark, 2300
    Public contact
    Clinical Development Support, Ferring Pharmaceuticals, DK0-Disclosure@ferring.com
    Scientific contact
    Clinical Development Support, Ferring Pharmaceuticals, DK0-Disclosure@ferring.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
    11 Sep 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 May 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Sep 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the effects of barusiban and atosiban compared to placebo on luteal phase uterine contractions in oocyte donors supplemented with progesterone
    Protection of trial subjects
    The trial was performed in accordance with the Declaration of Helsinki and its amendments in force at the initiation of the trial.
    Background therapy
    Progesterone (utrogestan), as non-investigational medicinal product (NIMP), was dispensed to subjects who were screened and included in the trial.
    Evidence for comparator
    This was a randomised controlled trial with placebo as the comparator to adequately document the efficacy and safety of barusiban and atosiban. A placebo group was justified for this trial as there is no therapy available for this indication.
    Actual start date of recruitment
    13 Nov 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
    Belgium: 33
    Country: Number of subjects enrolled
    Czech Republic: 53
    Country: Number of subjects enrolled
    Spain: 39
    Worldwide total number of subjects
    125
    EEA total number of subjects
    125
    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)
    125
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    A total of 5 sites randomised subjects into the trial : 1 in Belgium, 2 in Spain, and 2 in Czech Republic.

    Pre-assignment
    Screening details
    A total of 129 subjects were screened in the trial, of whom 125 subjects were randomised: 41 to barusiban, 42 to atosiban and 42 to placebo.

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Barusiban
    Arm description
    Subjects randomised to barusiban investigational medicinal product (IMP) were included in this group.
    Arm type
    Experimental

    Investigational medicinal product name
    Barusiban
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received barusiban (Intravenous [IV] bolus 9 mg followed by an IV infusion of 2.16 mg/h). The IV bolus volume was 0.9 mL administered over 1 minute and the infusion rate was 24 mL/h for approximately 4 hours. Total amount of exposure to barusiban was 17.64 mg (9.0 mg bolus + 8.64 mg infused).

    Arm title
    Atosiban
    Arm description
    Subjects randomised to atosiban IMP were included in this group.
    Arm type
    Experimental

    Investigational medicinal product name
    Atosiban
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received atosiban (IV bolus 6.75 mg followed by an IV infusion of 18 mg/h). The IV bolus volume was 0.9 mL administered over 1 minute and the infusion rate was 24 mL/h for approximately 4 hours. Total amount of exposure to atosiban was 78.75 mg (6.75 mg bolus + 72.0 mg infused).

    Arm title
    Placebo
    Arm description
    Subjects randomised to placebo IMP were included in this group.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received IV bolus of saline (sodium chloride 0.9%) followed by an IV infusion of saline. The IV bolus volume was 0.9 mL administered over 1 minute and the infusion rate was 24 mL/h for approximately 4 hours.

    Number of subjects in period 1
    Barusiban Atosiban Placebo
    Started
    41
    42
    42
    Completed
    41
    41
    42
    Not completed
    0
    1
    0
         Adverse event, non-fatal
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Barusiban
    Reporting group description
    Subjects randomised to barusiban investigational medicinal product (IMP) were included in this group.

    Reporting group title
    Atosiban
    Reporting group description
    Subjects randomised to atosiban IMP were included in this group.

    Reporting group title
    Placebo
    Reporting group description
    Subjects randomised to placebo IMP were included in this group.

    Reporting group values
    Barusiban Atosiban Placebo Total
    Number of subjects
    41 42 42 125
    Age categorical
    Data are presented for the ITT analysis set.
    Units: Subjects
        In utero
    0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0
        Newborns (0-27 days)
    0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0
        Children (2-11 years)
    0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0
        Adults (18-64 years)
    41 42 42 125
        From 65-84 years
    0 0 0 0
        85 years and over
    0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    41 42 42 125
        Male
    0 0 0 0
    Subject analysis sets

    Subject analysis set title
    Intention-to-treat (ITT) analysis set
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    All randomised and exposed subjects providing data on the frequency of uterine contractions 3 hours after start of dosing were included in this analysis set.

    Subject analysis set title
    Per Protocol (PP) analysis set
    Subject analysis set type
    Per protocol
    Subject analysis set description
    All subjects in the ITT analysis set except those who met any of the criteria considered as major protocol deviations were included in this analysis set.

    Subject analysis set title
    Safety Analysis Set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All randomised and exposed subjects were included in this analysis set.

    Subject analysis sets values
    Intention-to-treat (ITT) analysis set Per Protocol (PP) analysis set Safety Analysis Set
    Number of subjects
    117
    112
    125
    Age categorical
    Data are presented for the ITT analysis set.
    Units: Subjects
        In utero
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
        Adults (18-64 years)
    117
    112
    125
        From 65-84 years
    0
    0
    0
        85 years and over
    0
    0
    0
    Age continuous
    Units:
        
    ±
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    117
    112
    125
        Male
    0
    0
    0

    End points

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    End points reporting groups
    Reporting group title
    Barusiban
    Reporting group description
    Subjects randomised to barusiban investigational medicinal product (IMP) were included in this group.

    Reporting group title
    Atosiban
    Reporting group description
    Subjects randomised to atosiban IMP were included in this group.

    Reporting group title
    Placebo
    Reporting group description
    Subjects randomised to placebo IMP were included in this group.

    Subject analysis set title
    Intention-to-treat (ITT) analysis set
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    All randomised and exposed subjects providing data on the frequency of uterine contractions 3 hours after start of dosing were included in this analysis set.

    Subject analysis set title
    Per Protocol (PP) analysis set
    Subject analysis set type
    Per protocol
    Subject analysis set description
    All subjects in the ITT analysis set except those who met any of the criteria considered as major protocol deviations were included in this analysis set.

    Subject analysis set title
    Safety Analysis Set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All randomised and exposed subjects were included in this analysis set.

    Primary: Frequency of uterine contractions at 3 hours after start of dosing

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    End point title
    Frequency of uterine contractions at 3 hours after start of dosing
    End point description
    Data are presented for the ITT analysis set.
    End point type
    Primary
    End point timeframe
    At 3 hours after start of dosing.
    End point values
    Barusiban Atosiban Placebo
    Number of subjects analysed
    38
    36
    36
    Units: contractions/min
        arithmetic mean (standard deviation)
    2.72 ± 0.991
    2.81 ± 0.947
    3.14 ± 1.11
    Statistical analysis title
    Frequency at 3 hours- atosiban vs placebo
    Statistical analysis description
    Analysis of contraction frequency at 3 hours after start of dosing was done using analysis of variance (ANOVA) on the ITT analysis set.
    Comparison groups
    Placebo v Atosiban
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.166
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.335
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.811
         upper limit
    0.141
    Statistical analysis title
    Frequency at 3 hours- barusiban vs placebo
    Statistical analysis description
    Analysis of contraction frequency at 3 hours after start of dosing was done using analysis of variance (ANOVA) on the ITT analysis set.
    Comparison groups
    Placebo v Barusiban
    Number of subjects included in analysis
    74
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.075
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.426
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.896
         upper limit
    0.043

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall Treatment Period
    Adverse event reporting additional description
    Treatment-emergent adverse events (TEAEs) were presented and evaluated by treatment groups. Data were presented for safety analysis set.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    10.1
    Reporting groups
    Reporting group title
    Barusiban
    Reporting group description
    Subjects randomised to barusiban IMP were included in this group.

    Reporting group title
    Atosiban
    Reporting group description
    Subjects randomised to atosiban IMP were included in this group.

    Reporting group title
    Placebo
    Reporting group description
    Subjects randomised to placebo IMP were included in this group.

    Serious adverse events
    Barusiban Atosiban Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Barusiban Atosiban Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 41 (7.32%)
    1 / 42 (2.38%)
    3 / 42 (7.14%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 42 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    1
    0
    1
    Syncope vasovagal
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 42 (2.38%)
    0 / 42 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
         occurrences all number
    1
    0
    0
    Reproductive system and breast disorders
    Ovarian hyperstimulation syndrome
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 42 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 42 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Influenza
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
         occurrences all number
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 May 2008
    Two protocol changes were introduced in this amendment: the inclusion of a new secondary endpoint, and addition of uterine description and transvaginal ultrasound quality parameters.

    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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