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    Clinical Trial Results:
    Pre-treatment with Mifepristone prior to Mirena insertion for optimizing bleeding pattern in pre-menopausal women

    Summary
    EudraCT number
    		 2009-009014-40
    Trial protocol
    		 SE  
    Global end of trial date
    30 Jan 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Mar 2021
    First version publication date
    31 Mar 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    W2009M
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01931657
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Karolinska Institutet
    Sponsor organisation address
    17177, Stockholm, Sweden,
    Public contact
    Kristina Gemzell Danielsson, Karolinska Institutet, kristina.gemzell@ki.se
    Scientific contact
    Kristina Gemzell Danielsson, Karolinska Institutet, kristina.gemzell@ki.se
    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
    30 Jan 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jan 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jan 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of the present study is to study in pre-menopausal women requesting Mirena for contraception: 1. the effect of pre-treatment with mifepristone on the bleeding pattern in women using the Mirena contraceptive system
    Protection of trial subjects
    Follow-up was done with visits to the clinic monthly for the first 3 months, at 6 months post LNGIUS insertion and with a telephone contact at the 12 months end-of-trial evaluation. Also, a transvaginal ultrasound examination was performed at baseline, prior to LNG-IUS insertion and then monthly for 3 months after the LNG-IUS insertion as well as at 6 months after insertion.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Nov 2009
    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
    Sweden: 58
    Worldwide total number of subjects
    58
    EEA total number of subjects
    58
    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)
    58
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This was a prospective, randomized, double blind, placebo-controlled trial to evaluate the effect of pre-treatment with a low dose mifepristone on bleeding pattern in women requesting LNG-IUS 52 mg as a contraceptive method. The study was conducted at the Karolinska University Hospital from November 2009 to January 2015.

    Pre-assignment
    Screening details
    		 Screening criteria: healthy women, opting for LNG-IUS 52 mg for contraception, aged 18–43 with regular and normal menstrual cycles lasting 24–35 days, with no contraindications to LNG-IUS or mifepristone.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Women received mifepristone (Mifegyne®, Exelgyn, Paris, France) or visually indistinguishable vitamin B (TrioBe® Recip, Stockholm, Sweden). The tablets were divided by the study nurse.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Mifepristone
    Arm description
    		 50 mg mifepristone) was to be taken orally every other day starting on the first day of the menstrual cycle for the pre-treatment period. The pre-treatment period was 2 months (corresponding to two menstrual cycles i.e. 2 × 28 days) prior to insertion and until 3 days (±2 days) following the LNG-IUS insertion.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mifepristone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50 mg every other day starting on the first day of the menstrual cycle for the pre-treatment period. The pre-treatment period was 2 months (corresponding to two menstrual cycles i.e. 2 × 28 days) prior to insertion and until 3 days (±2 days) following the LNG-IUS insertion.

    Arm title
    		 Placebo
    Arm description
    		 Women in placebo received visually indistinguishable vitamin B (TrioBe® Recip, Stockholm, Sweden) and was to be taken orally every other day starting on the first day of the menstrual cycle for the pre-treatment period. The pre-treatment period was 2 months (corresponding to two menstrual cycles i.e. 2 × 28 days) prior to insertion and until 3 days (±2 days) following the LNG-IUS insertion.
    Arm type
    		 Placebo

    Investigational medicinal product name
    TrioB
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One quarter of the comparator (TrioB) was to be taken orally every other day starting on the first day of the menstrual cycle for the pre-treatment period. The pre-treatment period was 2 months (corresponding to two menstrual cycles i.e. 2 × 28 days) prior to insertion and until 3 days (±2 days) following the LNG-IUS insertion.

    Number of subjects in period 1
    		Mifepristone Placebo
    Started
    29
    29
    Completed
    26
    23
    Not completed
    3
    6
         Consent withdrawn by subject
    3
    3
         Pregnancy
    -
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Mifepristone
    Reporting group description
    		 50 mg mifepristone) was to be taken orally every other day starting on the first day of the menstrual cycle for the pre-treatment period. The pre-treatment period was 2 months (corresponding to two menstrual cycles i.e. 2 × 28 days) prior to insertion and until 3 days (±2 days) following the LNG-IUS insertion.

    Reporting group title
    Placebo
    Reporting group description
    		 Women in placebo received visually indistinguishable vitamin B (TrioBe® Recip, Stockholm, Sweden) and was to be taken orally every other day starting on the first day of the menstrual cycle for the pre-treatment period. The pre-treatment period was 2 months (corresponding to two menstrual cycles i.e. 2 × 28 days) prior to insertion and until 3 days (±2 days) following the LNG-IUS insertion.

    Reporting group values
    		 Mifepristone Placebo Total
    Number of subjects
    		 29 29 58
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 31 (20 to 41) 27 (20 to 43) -
    Gender categorical
    Units: Subjects
        Female
    		 29 29 58
        Male
    		 0 0 0
    Pregnancies
    Units: Number
        median (full range (min-max))
    		 1.5 (0 to 5) 1 (0 to 5) -
    Parity
    Units: Number
        median (full range (min-max))
    		 0 (0 to 3) 0 (0 to 4) -
    Cycle lengths
    Units: Days
        median (full range (min-max))
    		 29 (27 to 32) 28 (24 to 35) -
    Duration of menstrual period
    Units: Days
        median (full range (min-max))
    		 5 (3 to 7) 5 (3 to 7) -
    BMI
    Units: BMI
        median (full range (min-max))
    		 22.9 (18.2 to 30.4) 23.8 (18.4 to 32.0) -

    End points

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    End points reporting groups
    Reporting group title
    Mifepristone
    Reporting group description
    		 50 mg mifepristone) was to be taken orally every other day starting on the first day of the menstrual cycle for the pre-treatment period. The pre-treatment period was 2 months (corresponding to two menstrual cycles i.e. 2 × 28 days) prior to insertion and until 3 days (±2 days) following the LNG-IUS insertion.

    Reporting group title
    Placebo
    Reporting group description
    		 Women in placebo received visually indistinguishable vitamin B (TrioBe® Recip, Stockholm, Sweden) and was to be taken orally every other day starting on the first day of the menstrual cycle for the pre-treatment period. The pre-treatment period was 2 months (corresponding to two menstrual cycles i.e. 2 × 28 days) prior to insertion and until 3 days (±2 days) following the LNG-IUS insertion.

    Primary: Bleeding pattern in women after insertion of the LNG-IUS

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    End point title
    		 Bleeding pattern in women after insertion of the LNG-IUS
    End point description
    End point type
    Primary
    End point timeframe
    3 months after insertion of the LNG-IUS.
    End point values
    		 Mifepristone Placebo
    Number of subjects analysed
    19
    19
    Units: % days with bleeding and spotting
    40
    38
    Statistical analysis title
    		 Difference in bleeding patterns
    Statistical analysis description
    Difference in percentage days with bleeding and spotting 3 months following insertion of the LNG-IUS.
    Comparison groups
    Mifepristone v Placebo
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.838
    Method
    		 Mann-Whitney U-test
    Parameter type
    		 Median difference (final values)
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From pre-treatment with Mifepristone and up to 12 months after insertion of LNG-IUS.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 ICD
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Mifepristone
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Mifepristone Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Mifepristone Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: There were no side effects or non-serious adverse events related to the study treatment, other than bleeding. But bleeding was a main outcome, so it was not counted as an adverse event.

    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.
    Limitations of the study include its small sample size, and the fact that the observed difference in bleeding and spotting days between study groups was small and short lasting.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/30295731
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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