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    Summary
    EudraCT Number:2020-006147-25
    Sponsor's Protocol Code Number:UTEROXINE
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2024-06-04
    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 number2020-006147-25
    A.3Full title of the trial
    Botulinum toxin type A injection in patients with chronic pelvic pain of uterine origin (severe dysmenorrhea and/or deep dyspareunia).

    Phase III, single-center, randomized study vs. control group
    Injection de Toxine botulinique de type A chez des patientes atteintes de douleurs pelviennes chroniques d’origine utérine (dysménorrhées sévères et/ou de dyspareunies profondes).

    Étude de phase III, monocentrique, randomisée vs groupe contrôle
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Botulinum toxin type A injection in patients with chronic pelvic pain of uterine origin

    Phase III, single-center, randomized study vs. control group
    Injection de Toxine botulinique de type A chez des patientes atteintes de douleurs pelviennes chroniques d’origine utérine

    Étude de phase III, monocentrique, randomisée vs groupe contrôle
    A.3.2Name or abbreviated title of the trial where available
    UTEROXINE
    UTEROXINE
    A.4.1Sponsor's protocol code numberUTEROXINE
    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 SponsorCentre de Recherche en Santé de la Femme
    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 supportCentre de Recherche en Santé de la Femme
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportLaboratoire MERZ
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMyCRO
    B.5.2Functional name of contact pointNathalie MANON
    B.5.3 Address:
    B.5.3.1Street Address479 chemin du bes
    B.5.3.2Town/ cityPEYROLLES EN PROVENCE
    B.5.3.3Post code13860
    B.5.3.4CountryFrance
    B.5.4Telephone number0033750123238
    B.5.6E-mailmycro.contact@gmail.com
    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 XEOMIN 200
    D.2.1.1.2Name of the Marketing Authorisation holderMERZ PHARMACEUTICALS GMBH
    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 nameToxine botulinique
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntrauterine use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    PATIENTS WITH CHRONIC PELVIC PERINEAL PAIN OF UTERINE ORIGIN WITH VAS>4
    PATIENTES PRÉSENTANT DES DOULEURS PELVI-PERINEALES CHRONIQUES D'ORIGINE UTÉRINE AVEC EVA>4
    E.1.1.1Medical condition in easily understood language
    PATIENTS WITH CHRONIC PELVIC PERINEAL PAIN OF UTERINE ORIGIN WITH VAS>4
    PATIENTES PRÉSENTANT DES DOULEURS PELVI-PERINEALES CHRONIQUES D'ORIGINE UTÉRINE AVEC EVA>4
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10048581
    E.1.2Term Pelvic pain female
    E.1.2System Organ Class 10038604 - Reproductive system and breast disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10064189
    E.1.2Term Chronic pelvic pain syndrome
    E.1.2System Organ Class 10038604 - Reproductive system and breast disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10078087
    E.1.2Term Genito-pelvic pain/penetration disorder
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10011990
    E.1.2Term Deep dyspareunia
    E.1.2System Organ Class 10038604 - Reproductive system and breast disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10013934
    E.1.2Term Dysmenorrhea
    E.1.2System Organ Class 10038604 - Reproductive system and breast disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to assess the effectiveness of TB, measured through improvement in quality of life assessed by the Patient Global Impression of Improvement (PGI-I) symptom score
    L'objectif principal est d'évaluer l'efficacité de TB, mesurée à travers l'amélioration de la qualité de vie évaluée par le score de symptômes Patient Global Impression of Improvement (PGI-I) : Impression Globale d'Amélioration de la Patiente.
    E.2.2Secondary objectives of the trial
    To have a complete assessment of the quality of life, the result of the

    treatment will also be
    evaluated by different self-questionnaires:
    - The EQ-5D-3L evaluating the state of health in a general and generic
    way
    - Leeds questionnaire to evaluate quality of sleep
    - The FSFI evaluating female sexual function
    - The digital scale of deep dyspareunia and dysmenorrhea,
    - Assessment of pain by the patient using a visual analogue scale
    - The study of side effects / drug tolerance / surgical complications
    - Assessment of the patient's overall satisfaction
    All data will be compared between the treatment group (uterine TB
    injections under
    hysteroscopy) and the control group
    Pour avoir une évaluation complète de la qualité de vie, le résultat du

    traitement sera également
    évalué par différents auto-questionnaires :
    - L'EQ-5D-3L évaluant l'état de santé de manière globale et générique
    - Questionnaire Leeds pour évaluer la qualité du sommeil
    - Le FSFI évaluant la fonction sexuelle féminine
    - L'échelle numérique des dyspareunies profondes et dysménorrhées,
    - L'évaluation de la douleur par la patiente à l'aide d'une échelle visuelle
    analogique
    - L'étude des effets secondaires/tolérance médicamenteuse /
    complications chirurgicales
    - L'évaluation de la satisfaction globale de la patiente
    Toutes les données seront comparées entre le groupe de traitement
    (injections de TB utérines sous
    hystéroscopie) et le groupe contrôle
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Be of age,
    - Present chronic pain of uterine origin VAS > 4 for at least 6 months,
    - These chronic pains of uterine origin can be due to severe dysmenorrhoea and/or deep dyspareunia and/or polycystic ovarian syndrome and/or fibroma and/or adenomyosis and/or superficial endometriosis, i.e. without involvement of organs other than gynaecological (e.g.: bladder, bowel, ureteral or more distant involvement)
    - To have been treated for these pains for at least 3 months, including at least a hormonal treatment and/or an analgesic treatment, or to have tried this treatment for at least 3 months, or to refuse this treatment, or intolerance, or contra-indication,
    - Be physically able to withstand a general anesthesia
    - To comply with the pre-anesthesia consultation before the operation
    - Have sufficient cooperation and understanding to comply with the requirements of the study,
    - Agree to give written consent,
    - Be affiliated with the French Social Security system.
    - Être majeure,
    - Présenter des douleurs chroniques d’origine utérine EVA > 4 depuis au moins 6 mois,
    - Ces douleurs chroniques d’origine utérine peuvent être dues à des dysmenorrhées sévères et/ou des dyspareunies profondes et/ou un syndrôme des ovaires polykystiques et/ou un fibrome et/ou une adenomyose et/ou une endométriose superficielle c’est à dire sans atteinte d’organes autres que gynécologiques (exemple : atteinte vésicale, intestinale, urétérale ou plus éloignée)
    - Être traitée pour ces douleurs depuis au moins 3 mois, incluant au moins un traitement hormonal et/ou un traitement antalgique, ou avoir essayer ce traitement pendant au moins 3 mois, ou refuser ce traitement, ou intolérance, ou contre-indication,
    - Etre en capacité physique de supporter une anesthésie générale
    - Se conformer à la consultation de préanesthésie avant l’intervention
    - Avoir une coopération et une compréhension suffisantes pour se conformer aux impératifs de l’étude,
    - Accepter de donner un consentement écrit,
    - Être affiliée au régime de la Sécurité Sociale française.
    E.4Principal exclusion criteria
    - Be a minor,
    - Have a contraindication to botulinum toxin: myasthenia, anticoagulant and antiplatelet agents, coagulation disorders, treatment with an aminoglycoside,
    - Hypersensitivity to the active substance or to human albumin or sucrose,
    - Have a contraindication to general anesthesia
    - Not to have attended the pre-anesthesia consultation
    - Pelvic ultrasound and/or laparoscopy and/or pelvic MRI showing deep endometriosis-type abnormalities except adenomyosis,
    - Have generalized muscle activity disorders (e.g. myasthenia gravis, Lambert-Eaton syndrome),
    - Have an infection or inflammation of the uterine wall,
    - Have active cervical cancer or any other history of malignancy within 5 years prior to inclusion, with the exception of non-melanoma skin cancer treated without evidence of recurrence.
    - Be pregnant or breastfeeding,
    - Participating in another clinical trial, or being in the exclusion period,
    - Have a level of cooperation and understanding that does not allow strict compliance with the conditions of the protocol,
    - To benefit from a legal protection measure (curatorship, guardianship...),
    - Not be affiliated to the French Social Security system.
    - Être mineure,
    - Avoir une contre-indication à la toxine botulinique : myasthénie, anticoagulant et antiagrégants plaquettaires, troubles de la coagulation, traitement par un aminoside,
    - Avoir une hypersensibilité à la substance active ou à l’albumine humaine ou à la saccharose,
    - Avoir une contre-indication à l’anesthésie générale
    - Ne pas s’être présentée à la consultation de préanesthésie
    - Avoir une échographie pelvienne et/ou cœlioscopie et/ou IRM pelvienne retrouvant des anomalies à type d’endométriose profonde sauf adénomyose,
    - Avoir des troubles généralisés de l'activité musculaire (ex : myasthénie gravis, syndrome de Lambert-Eaton),
    - Avoir une infection ou une inflammation de la paroi utérine,
    - Avoir un cancer du col de l’utérus actif ou tout autre antécédent de tumeur maligne dans les 5 ans précédant l’inclusion, à l'exception d'un cancer de la peau sans mélanome traité sans signe de récidive.
    - Être enceinte ou allaitante,
    - Participer à un autre essai clinique, ou se trouvant dans la période d’exclusion,
    - Avoir une coopération et une compréhension ne permettant pas de se conformer de façon stricte aux conditions prévues par le protocole,
    - Bénéficier d’une mesure de protection légale (curatelle, tutelle…),
    - Ne pas être affiliée au régime de la Sécurité Sociale française.
    E.5 End points
    E.5.1Primary end point(s)
    Questionnaire Patient Global Impression of Improvement (PGI-I)
    Questionnaire Patient Global Impression of Improvement (PGI-I)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Questionnaires will be answered at inclusion before injection, then, 2, 6 and 16 weeks after injection
    Les questionnaires seront remplis à l'inclusion avant l'injection, puis, 2, 6 et 16 semaines après l'injection.
    E.5.2Secondary end point(s)
    - Overall Quality of Life Score: EQ-5D-3L
    - Specific quality of life score: EHP-30
    - Leeds questionnaire on sleeping quality
    - Score of female sexual function: FSFI
    - Annoyance score: Numerical scale (EN) for deep dyspareunia and
    dysmenorrhea
    - Assessment of pain by the patient using a Visual Analog Scale (VAS)
    - Side effects / drug tolerance / Surgical complications
    - Assessment of the patient's overall satisfaction
    - Medico-economic questionnaire
    - Score de qualité de vie globale : EQ-5D-3L
    - Score de qualité de vie spécifique : EHP-30
    - Questionnaire Leeds sur la qualité du sommeil
    - Score de la fonction sexuelle féminine : FSFI
    - Score de gêne : Échelle numérique (EN) des dyspareunies profondes et
    dysménorrhées
    - Évaluation de la douleur par la patiente à l'aide d'une Échelle Visuelle
    Analogique (EVA)
    - Effets secondaires / tolérance médicamenteuse / Complications
    chirurgicales
    - Évaluation de la satisfaction globale de la patiente
    - Questionnaire médico-économique
    E.5.2.1Timepoint(s) of evaluation of this end point
    Questionnaires will be answered at inclusion before injection, then, 2, 6 and 16 weeks after injection
    Les questionnaires seront remplis à l'inclusion avant l'injection, puis, 2, 6 et 16 semaines après l'injection.
    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 Yes
    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 Yes
    E.8.1.3Single blind No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    traitement classique : hormonal et/ou antalgique
    standard of care : hormonal and/or antalgic treatment
    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
    End of study will occur 4 month (+/- 15 days) after last patient injection
    La fin de l'étude aura lieu 4 mois (+/- 15 jours) après l'injection de la dernière patiente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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: 100
    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 Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    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 state100
    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
    Néant
    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 Decision2022-11-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-17
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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