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    Clinical Trial Results:
    A double-blind, randomized, multicenter study evaluating 200 mg versus 600 mg of Mifepristone on pain in voluntary abortion by drug prior to 7 SA.

    Summary
    EudraCT number
    		 2017-004083-35
    Trial protocol
    		 FR  
    Global end of trial date
    04 Apr 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Jun 2026
    First version publication date
    11 Jun 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2017-53
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03659045
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Assistance - Publique Hôpitaux de Marseille
    Sponsor organisation address
    80 rue Brochier, Marseille, France, 13354
    Public contact
    Marjorie Saccone, Assistance - Publique Hôpitaux de Marseille, +33 0491381966, marjorie.saccone@ap-hm.fr
    Scientific contact
    Marjorie Saccone, Assistance - Publique Hôpitaux de Marseille, +33 0491381966, marjorie.saccone@ap-hm.fr
    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
    04 Apr 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Apr 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Apr 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this research is to compare the efficacy in reducing the pain of two doses of Mifegyne during medicinal abortion before 7 Weeks of amenorrhea (600 versus 200 mg).
    Protection of trial subjects
    Analgesics
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Jan 2019
    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: 320
    Worldwide total number of subjects
    320
    EEA total number of subjects
    320
    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)
    320
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Critères d’inclusion : Femme âgée de 18 ans ou plus; Présentant une grossesse intra-utérine unique, dont le terme est inférieur à 7 SA le jour de la prise de Mifépristone, estimé par échographie avec une mesure de la longueur crânio-caudale inférieure ou égale à 10 millimètres ; Désirant une IVG médicamenteuse en milieu hospitalier ; Ayant signé CE

    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, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Groupe 600 mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    MIFEPRISTONE
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Buccal tablet
    Routes of administration
    Buccal use
    Dosage and administration details
    3 comprimés de 200 mg par voie orale

    Arm title
    		 Goupe 200 mg
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Groupe 600 mg Goupe 200 mg
    Started
    160
    160
    Completed
    160
    160

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Groupe 600 mg
    Reporting group description
    		 -

    Reporting group title
    Goupe 200 mg
    Reporting group description
    		 -

    Reporting group values
    		 Groupe 600 mg Goupe 200 mg Total
    Number of subjects
    		 160 160 320
    Age categorical
    Units: Subjects
        Femme majeur
    		 160 160 320
    Gender categorical
    Units: Subjects
        FEMALE
    		 160 160 320

    End points

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    End points reporting groups
    Reporting group title
    Groupe 600 mg
    Reporting group description
    		 -

    Reporting group title
    Goupe 200 mg
    Reporting group description
    		 -

    Primary: Evaluation de la douleur

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    End point title
    		 Evaluation de la douleur
    End point description
    End point type
    Primary
    End point timeframe
    5h suivant la prise de misoprostol
    End point values
    		 Groupe 600 mg Goupe 200 mg
    Number of subjects analysed
    160
    160
    Units: NA
    160
    160
    Statistical analysis title
    		 Critère principal
    Statistical analysis description
    La moyenne du niveau de douleur sur les 5 temps horaires initiaux : La moyenne est calculée sur les 5 EN de la base de données. doul_mean = Mean (douleur_1h, douleur_2h, douleur_3h, douleur_4h, douleur_5h) Pour rappel, la moyenne est calculée sur les données renseignées : - si aucune donnée sur les 5 EN : pas de calcul, donnée manquante. - si 0 ou 4 données manquantes, la moyenne est calculée sur les données renseignées.
    Comparison groups
    Groupe 600 mg v Goupe 200 mg
    Number of subjects included in analysis
    320
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 ≤ 0 [2]
    Method
    		 Mann-Whitney
    Confidence interval
    Notes
    [1] - L’analyse est réalisée en intention de traiter sur un set ‘modified intent-to-treat’
    [2] - Les P-valeurs sont produites à titre indicatif seulement.

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    No timeframe for adverse event reporting by the investigator to the promotor Timeframe for serious adverse event reporting by the investigator to the promotor : within 24 hours
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Frequency threshold for reporting non-serious adverse events: 5%
    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: Les évènements indésirables non graves ont été recueillis pour cette étude et correspondent aux critères de jugements.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Oct 2018
    La modification porte sur le conditionnement et l’étiquetage des unités thérapeutiques afin de respecter la mise en aveugle.
    09 Jul 2019
    La modification porte sur un critère de non inclusion
    07 Jan 2020
    Changement d’investigateur Principal dans un centre associé
    21 Oct 2020
    Mise à jour du protocole, du document d’information et du formulaire de consentement conformément au RGPD.
    03 Feb 2021
    Prolongation de la durée d’étude
    07 Jul 2021
    Suspension temporaire des inclusions à partir du 06/07/2021.
    09 Aug 2022
    Reprise des inclusions Modification de critères de non inclusion Correction d’une erreur dans le critère de jugement principal Prolongation de la durée d’étude Mise à jour du protocole et de la note d’information patiente
    08 Feb 2023
    mise à jour de la version du RCP de la MYFEGYNE 200mg + Ajout d'un critère de non inclusion + Ajout d'un critère d'exclusion

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    06 Jul 2021
    Suspension temporaire des inclusions à partir du 06/07/2021. Motif de l’arrêt : conformément aux engagements pris par l’APHM suite à une inspection dans l’attente d’une mise en conformité de la cellule vigilance.
    09 Aug 2022

    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
    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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