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    Summary
    EudraCT Number:2019-000300-16
    Sponsor's Protocol Code Number:P170923J
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2020-08-12
    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 number2019-000300-16
    A.3Full title of the trial
    NA
    Evaluation de l’efficacité du traitement hormonal chez les adolescents souffrant de dysphorie de genre
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NA
    NA
    A.3.2Name or abbreviated title of the trial where available
    TRANSADO
    A.4.1Sponsor's protocol code numberP170923J
    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 - HOPITAUX DE PARIS
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMinistère de la Santé et des Solidarités
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
    B.5.2Functional name of contact pointChef de projet
    B.5.3 Address:
    B.5.3.1Street AddressDirection de la Recherche Clinique et de l'Innovation, Hôpital Saint Louis, 1 av Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number33144.84.17.30
    B.5.5Fax number33144.84.17.01
    B.5.6E-mailyannick.vacher@aphp.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 ANDROTARDYL 250 mg/1mL, solution injectable intramusculaire
    D.2.1.1.2Name of the Marketing Authorisation holderBAYER HEALTHCARE
    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 nameANDROTARDYL
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTESTOSTERONE ENANTATE
    D.3.9.1CAS number 315-37-7
    D.3.9.4EV Substance CodeSUB04736MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 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 PROVAMES 1 mg, comprimé pelliculé
    D.2.1.1.2Name of the Marketing Authorisation holderMERUS LABS LUXCO II S.A R.L.
    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 namePROVAMES
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNESTRADIOL
    D.3.9.3Other descriptive nameESTRADIOL, MICRONIZED
    D.3.9.4EV Substance CodeSUB183850
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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: 3
    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 PROVAMES 2 mg, comprimé pelliculé
    D.2.1.1.2Name of the Marketing Authorisation holderMERUS LABS LUXCO II S.A R.L.
    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 namePROVAMES
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNESTRADIOL
    D.3.9.3Other descriptive nameESTRADIOL, MICRONIZED
    D.3.9.4EV Substance CodeSUB183850
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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: 4
    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 ESTREVA 0.1%, gel
    D.2.1.1.2Name of the Marketing Authorisation holderTHERAMEX IRELAND LIMITED
    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 nameESTREVA
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNESTRADIOL HEMIHYDRATE
    D.3.9.3Other descriptive nameESTRADIOL HEMIHYDRATE
    D.3.9.4EV Substance CodeSUB11941MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    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
    NA
    Dysphorie de genre
    E.1.1.1Medical condition in easily understood language
    NA
    Dysphorie de genre
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Psychological processes [F02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10078075
    E.1.2Term Gender dysphoria
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    NA
    Evaluer, chez les adolescents dysphoriques de genre, ayant réalisé leur transition sociale, ayant ou non bénéficié d’une suppression pubertaire préalable, l’efficacité du traitement hormonal par œstrogènes ou testostérone initié à 14 ans sur le fonctionnement global de l’adolescent à 16 ans.
    E.2.2Secondary objectives of the trial
    NA
    Evaluer, chez les adolescents dysphoriques de genre ayant réalisé leur transition sociale, ayant ou non bénéficié d’une suppression pubertaire préalable :
    - l’efficacité du traitement hormonal débuté à 14 ans vs 16 ans sur le fonctionnement global de l’adolescent à 18 ans,
    - la sécurité (effets secondaires) du traitement hormonal débuté à 14 ans,
    - et la pertinence du traitement hormonal débuté à 14 ans sur d’autres paramètres évalués à 16 et 18 ans (identité de genre, dépression, anxiété, troubles émotionnels, comportementaux et autres comorbidités, qualité de vie objective et subjective, image du corps, taille, ratio tour de taille/tour de hanche, densité minérale osseuse, IMC).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    NA
    - Adolescents âgés de 14 ans+/- 6 mois,
    - Ayant une puberté initiée : score de tanner ≥2 pour les FtM ; score de tanner ≥2 et/ou testosterone >0,3ng/mL pour les MtF
    - présentant les critères de la dysphorie de genre selon le DSM5 évalués par au moins deux entretiens pédopsychiatriques à au moins six mois d’intervalle où a été cliniquement établi le diagnostic de dysphorie de genre et réfuté celui de trouble du spectre autistique associé et/ou de déficience cognitive associée, confirmé par les échelles spécifiques (Gender Identity / Gender Dysphoria Questionnaire for Adults and Adolescents (GIDYQ-AA), et Recalled Childhood Gender Identity Scale),
    - dont l’indication de transition hormonale a été validée en réunion de concertation pluridisciplinaire après au moins une consultation avec l’endocrinologue pédiatre avec examen clinique, prise de la pression artérielle, et information sur les traitements hormonaux dans le cadre de la dysphorie de genre.
    E.4Principal exclusion criteria
    NA
    - contre-indication au traitement hormonal
    - Nécessité d’aménagement du traitement hormonal (patient FtM traité par anti-coagulants).
    - troubles du spectre autistique (dépistage clinique, confirmé en cas de doute par la Social Responsiveness Scale (SRS) > 65ème percentile, réalisée dans le cadre de la prise en charge habituelle en cas d’argument clinique,
    - Déficit cognitif (dépistage clinique, confirmé par un QI < 80 à l’échelle de Weschler (WISC IV), réalisée dans le cadre de la prise en charge habituelle en cas d’argument clinique.
    - refus de participer à l’étude de la part de l’adolescent ou de l’un des titulaires de l’autorité parentale (les deux titulaires et l’adolescent devant signer un consentement écrit après avoir reçu une information adaptée).
    - absence de couverture par la sécurité sociale avec prise en charge au titre de l’ALD 31
    - Participation à une autre recherche interventionnelle

    E.5 End points
    E.5.1Primary end point(s)
    NA
    Score à la Children’s Global Assesment Scale (CGAS) à 16 ans.
    E.5.1.1Timepoint(s) of evaluation of this end point
    NA
    24 mois
    E.5.2Secondary end point(s)
    NA
    - Score à la Global Assesment Scale (GAS) à 18 ans +/- 6 mois.
    - Score à l’échelle de Weschler,
    - Score au Gender Identity/ Gender Dysphoria Questionnaire for Adolescents and Adults (GIDYQ-AA) et à l’Utrecht Gender Dysphoria Scale (UGDS),
    - Score à la Beck Depression Inventory (BDI),
    - Score à la Body Image Scale (BIS),
    - Score au State-Trait Anxiety Inventory for Children (STAIC),
    - Score à la Child Behaviour Checklist (CBCL),
    - Score au Youth Self Report (YSR),
    - Score à la Social Responsiveness Scale (SRS),
    - Score au World Health Organization Quality Of Life – BREF (WHOQOL-BREF),
    - Score à la Satisfaction With Life Scale (SWLS).
    - Taille, densité minérale osseuse, IMC, tour de taille / tour de hanche.
    - Effets secondaires potentiels : alopécie, acné, polyglobulie, dyslipidémie, hépathopathie pour les androgènes ; risque thromboembolique, hépathopathie, migraine, hyperprolactinémie pour les œstrogènes.
    - La relation affective et sexuelle : évaluée par des questions ciblées
    - La consommation de toxiques : évaluée par des questions ciblées
    - La déscolarisation / rupture familiale : évaluée par des questions ciblées
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    24 et 48 mois
    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 Yes
    E.6.5Efficacy No
    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 Yes
    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 hormonal démarré à 14 ans vs 16 ans
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years7
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 60
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 60
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 state60
    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)
    NA
    poursuite de la prise en charge selon les modalités habituelles
    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 Decision2020-10-07
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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