Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2016-003753-14
    Sponsor's Protocol Code Number:2016-35
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-09-23
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2016-003753-14
    A.3Full title of the trial
    CERVICAL PREPARATION UNDER PARACERVICAL BLOCK FOR THE ABORTION OF FIRST TRIMESTER: RANDOMIZED TRIAL
    PREPARATION CERVICALE DES IVG SOUS BLOC PARACERVICAL AU 1er TRIMESTRE: ESSAI CLINIQUE RANDOMISE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CERVICAL PREPARATION UNDER PARACERVICAL BLOCK FOR THE ABORTION OF FIRST TRIMESTER: RANDOMIZED TRIAL
    PREPARATION CERVICALE DES IVG SOUS BLOC PARACERVICAL AU 1er TRIMESTRE: ESSAI CLINIQUE RANDOMISE
    A.3.2Name or abbreviated title of the trial where available
    BPCEN
    BPCEN
    A.4.1Sponsor's protocol code number2016-35
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAssistance Publique Hôpitaux de Marseille
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAP-HM
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAssistance Publique Hôpitaux de Marseille
    B.5.2Functional name of contact pointCatherine GEINDRE
    B.5.3 Address:
    B.5.3.1Street AddressDirection de la Recherche et de l'Innovation, 80, rue Brochier
    B.5.3.2Town/ cityMarseille
    B.5.3.3Post code13354
    B.5.3.4CountryFrance
    B.5.4Telephone number+33491382747
    B.5.5Fax number+33491381479
    B.5.6E-mailkahena.amichi@ap-hm.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name MIFEPRISTONE 200 MG
    D.2.1.1.2Name of the Marketing Authorisation holderEXELGYN
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMIFEGYNE
    D.3.2Product code MIFEPRISTONE
    D.3.4Pharmaceutical form Cachet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name GYMISO 200MICROG
    D.2.1.1.2Name of the Marketing Authorisation holderHRA PHARMA
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGYMISO200MICROG
    D.3.2Product code GYMISO 200MICROG
    D.3.4Pharmaceutical form Cachet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The women are 18 years old or more, wishing an abortion under local anesthesia, between 6 and 14 weeks the day of the abortion.
    Patiente de 18 ans ou plus, désirant une interruption volontaire de grossesse (IVG) sous anesthésie locale (AL), entre 6semaines d'aménorhée (SA) et 14SA le jour de l'IVG
    E.1.1.1Medical condition in easily understood language
    The women are 18 years old or more, wishing an abortion under local anesthesia, between 6 and 14 weeks the day of the abortion.
    Patiente de 18 ans ou plus, désirant une interruption volontaire de grossesse (IVG) sous anesthésie locale, entre 6SA et 14SA le jour de l'IVG
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the level of per-operating pain during the surgical abortion under paracervical block in the first trimester after cervical preparation with mifepristone or misoprostol.
    Comparer le niveau de douleur per-opératoire des IVG instrumentales sous bloc para-cervical au premier trimestre après préparation cervicale à la mifepristone ou au misoprostol.
    E.2.2Secondary objectives of the trial
    compare two treatment strategies in terms of:
    • Pain during the suction phase after the mechanical dilation, immediate post-operative pain
    • Occurrence of perioperative complications: cervical tear, uterine perforation, hemorrhage
    • Response Time
    • Quantity of intraoperative bleeding
    • Lived perioperative documented by EVAN-LR self-administered questionnaire
    • Impact on the level of anxiety of the subjects by the STAI Anxiety Questionnaire
    • Tolerance (side effects, adverse events)
    • Satisfaction of patient, physician satisfaction
    comparer les 2 stratégies thérapeutiques en termes de:
    • Douleur pendant la phase d’aspiration après la dilatation mécanique, douleur post-opératoire immédiate
    • Survenue de complications per-opératoires : déchirure cervicale, perforation utérine, hémorragie
    • Durée d’intervention
    • Quantité de saignements per-opératoires
    • Vécu péri-opératoire documenté par l’auto-questionnaire EVAN-LR
    • Impact sur le degré d’anxiété des sujets par le questionnaire STAI d’anxiété
    • Tolérance (effets secondaires, évènements indésirables)
    • Satisfaction des patientes, satisfaction des médecins
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Women aged 18 or over;
    Woman with a single intrauterine pregnancy, the term is between 6SA and strictly less than 14 weeks on the day of the abortion, estimated by ultrasound measurement of the cranio-caudal length of between 5 and 84 millimeters;
    Female looking for abortions under local anesthesia;
    Women who have signed a written informed consent and agreeing to abide by the instructions of the protocol.
    Femme âgée de 18 ans ou plus ;
    Femme présentant une grossesse intra-utérine unique, dont le terme est compris entre 6SA et inférieur strictement à 14 SA le jour de l’IVG, estimé par échographie par une mesure de la longueur crânio-caudale comprise entre 5 et 84 millimètres ;
    Femme désirant une IVG sous AL ;
    Femme ayant signé un consentement éclairé écrit et s'engageant à respecter les instructions du protocole.
    E.4Principal exclusion criteria
    Woman wishing to interrupt her participation in the study before the end;
    Woman for whom surgery was not performed (no show the patient the day of surgery, miscarriage before the operation).
    Women who have not followed the protocol (not taken for a product).
    Femme souhaitant interrompre sa participation à l’étude avant la fin ;
    Femme pour laquelle l’intervention n’a pas été réalisée (non venue de la patiente le jour de l’intervention, fausse-couche avant l’intervention).
    Femme n’ayant pas suivi le protocole (non prise d’un produit).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of efficacy is represented by pain during expansion gathered immediately at the end of the mechanical dilation. The measurement is simple, reproducible, performed with an EN listed from 0 to 10 (0 no pain, 10 maximum pain experienced).
    Le critère de jugement principal d’efficacité est représenté par la douleur pendant la dilatation recueillie immédiatement à la fin de la dilatation mécanique. La mesure est simple, reproductible, effectuée à l’aide d’une EN cotée de 0 à 10 (0 absence de douleurs, 10 maximum de douleurs ressenties).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The evaluation of intraoperative pain occurs during the operation immediately after the mechanical dilation of the cervix.
    L'évaluation de la douleur per opératoire s'effectuera pendant l'intervention immédiatement après la dilatation mécanique du col.
    E.5.2Secondary end point(s)
    The duration of the intervention: this is the time between the passage of the first dilator and the end of the endo-uterine aspiration; it will be expressed in minutes;

    - Pre pain and post-operative will be assessed using EN at the entrance to the operating room and immediately at the end of the intervention, respectively;

    - Pain during the suction phase will be assessed using EN immediately at the end of the aspiration;

    - Intraoperative complications
    Intraoperative complications will be carefully documented, distinguishing between minor and major complications, including:
    - Cervical tear: injury to the neck after requiring the surgeon to suture hemostasis or reconstruction of the cervical anatomy;
    - Uterine perforation: diagnosis by the operator of uterine perforation intraoperative ultrasound or instrumental evaluation;
    - Bleeding of average gravity occurred between stopping the suction and duration considered significant bleeding requiring hospitalization cover of aspiration or injection of oxytocin;
    - Severe severity of hemorrhage occurred between stopping the suction and duration considered significant bleeding hospitalization requiring blood transfusion or uterine artery embolization or surgical hemostat (hysterectomy, arterial ligation).

    - Lived perioperative
    The experienced perioperative be evaluated postoperatively using a self-administered questionnaire (Auquier 1999 Pernoud 1999 Maurice 2011). This is a standardized questionnaire and validated, whose purpose is to understand the experience of perioperative anesthesia multidimensional way. There is a version for the regional anesthesia, called EVAN-LR (Mauritius-Szamburski, 2012).

    - Tolerance
    Tolerance will be assessed by examination prior to the start of the intervention. The following signs will be carefully collected nausea, vomiting, fever, diarrhea, abdominal pain, other (to be specified by the patient).

    - Anxiety
    The assessment of anxiety will be appreciated by placing the inventory trait anxiety (STAI). The STAI is a self-administered questionnaire developed by Spielberger (Spielberger, 1983) and validated in French (Gauthier & Bouchard, 1993). It includes 20 questions, assessing the usual emotional state of the subject. A score is calculated, a high score indicating the presence of anxiety.
    - Satisfaction
    The satisfaction of subjects will be assessed using a VAS, graduated from 0 to 10, filled out by the patient at the end of the intervention;
    Physician satisfaction will be assessed using a VAS, graduated from 0 to 10, filled out by the doctor at the end of the intervention.
    - La durée de l’intervention : il s’agit du délai entre le passage du premier dilatateur et la fin de l’aspiration endo-utérine ; elle sera exprimée en minutes ;

    - Les douleurs pré et post-opératoires seront appréciées à l’aide d’EN à l’entrée au bloc opératoire et immédiatement à la fin de l’intervention respectivement ;

    - La douleur pendant la phase d’aspiration sera appréciée à l’aide d’EN immédiatement à la fin de l’aspiration ;

    - Les complications per-opératoires
    Les complications per-opératoires seront minutieusement documentées, en distinguant des complications mineures et majeures, parmi lesquelles :
    - déchirure cervicale : lésion du col nécessitant d’après le chirurgien une suture pour hémostase ou reconstitution de l’anatomie cervicale ;
    - perforation utérine : diagnostic par l’opérateur d’une perforation utérine par échographie peropératoire ou évaluation instrumentale ;
    - hémorragie de gravité moyenne : survenue entre l’arrêt de l’aspiration et la durée d’hospitalisation de saignements jugés importants nécessitant une reprise de l’aspiration ou une injection d’ocytocique ;
    - hémorragie de gravité sévère : survenue entre l’arrêt de l’aspiration et la durée d’hospitalisation de saignements jugés importants nécessitant une transfusion sanguine ou une embolisation des artères utérines ou un geste chirurgical hémostatique (hystérectomie, ligature artérielle).

    - Vécu péri-opératoire
    Le vécu péri-opératoire sera évalué en post-opératoire à l’aide d’un auto-questionnaire (Auquier 1999, Pernoud 1999, Maurice 2011). Il s’agit d’un questionnaire standardisé et validé, dont la finalité est d’appréhender le vécu de la période péri-opératoire de l’anesthésie de manière multidimensionnelle. Il existe une version correspondant à l’anesthésie loco-régionale, appelée l’EVAN-LR (Maurice-Szamburski, 2012).

    - Tolérance
    La tolérance sera appréciée par l’interrogatoire avant le début de l’intervention. Les signes suivants seront minutieusement recueillis : nausées, vomissements, fièvre, diarrhée, douleurs abdominales, autres (à préciser par la patiente).

    - Anxiété
    L’évaluation de l’anxiété sera appréciée par la passation de l’Inventaire de trait d’anxiété (STAI). Le STAI est un auto-questionnaire, développé par Spielberger (Spielberger, 1983) et validé en français (Gauthier & Bouchard, 1993). Il comporte 20 questions, évaluant l’état émotionnel habituel du sujet. Un score est calculé, un score élevé indiquant la présence d’anxiété.
    - Satisfaction
    La satisfaction des sujets sera appréciée à l’aide d’une EVA, graduée de 0 à 10, remplie par la patiente à la fin de l’intervention ;
    La satisfaction du médecin sera appréciée à l’aide d’une EVA, graduée de 0 à 10, remplie par le médecin à la fin de l’intervention.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Preoperative -Pain collected immediately before the intervention.
    - Post operative pain collected after the intervention
    -satisfaction, anxiety, lived peri operative collected postoperative 1 hour after surgery
    -douleur préopératoire recueillie immédiatement avant l'intervention.
    - douleur post operatoire recueillie apres l'intervention
    -satisfaction, anxiete, vecu peri operatoire recueillis en post opératoire 1heure après l'intervention
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    Dernière visite du dernier sujet en cours de participation dans l'étude.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 110
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception Yes
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state1
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    aucun
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-12-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-03-13
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Sat May 04 06:12:58 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA