protocolSection identificationModule nctId: NCT06351501, orgStudyIdInfo id: P170923J, secondaryIdInfos id: 2019-000300-16, type: EUDRACT_NUMBER, briefTitle: Evaluation of the Effectiveness of Hormonal Treatment in Adolescents Suffering From Gender Dysphoria, acronym: TRANSADO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-06, primaryCompletionDateStruct date: 2029-06-06, completionDateStruct date: 2031-06-06, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: Gender dysphoria (GD) is a significant suffering lasting more than 6 months in a subject, regarding the gap felt between gender identity of someone and birth sex. From the start of puberty, most of these adolescents who identify as transgender will persist in this sense and will engage in hormonal-surgical reassignment at some stage. For these adolescents, International recommendations for good practice recommend early treatment at the beginning of pubertal development (Tanner 2) to block pubertal progression, with the possibility of hormonal transition by administration of sex hormones of the desired sex at the age of 16. However, in order to reduce the psychosocial consequences of GD, more and more reference teams are practicing this hormonal transition from the age of 14 without any randomized study showing its benefit compared to a transition at the age of 16 years old. Indeed, in the absence of treatment, comorbidities among adolescents suffering from gender dysphoria is very high, with anxiety and depression, suicidal risk and school dropout.Our hypothesis is that when hormonal transition is started at an age closer to what physiological puberty would be, it will reduce comorbidities and improve quality of life of these adolescents. This is the first therapeutic randomized study in France on this transgender adolescent population, a field where international recommendations based on "Evidence Based Medicine" principles are scared. We hope that results of this study will guide transgender youth health care allowing them, if the study is positive, to access hormonal treatments earlier and improve their overall functioning, their anxious and depressive symptoms, their quality of life., conditionsModule conditions: Cross Sex Hormonal Treatment in Adolescents With Gender Dysphoria, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: multicentric, controlled, randomized, open trial with blinded assessment of the primary outcome measure (Prospective Open Blinding Endpoint PROBE study), primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The evaluation of the main criterion by the CGAS will be administered by a psychologist trained on this scale who will not have knowledge of the adolescent's attribution group and will not have participated in their care, based on elements keys to the patient's file which will be provided to him without any element that could indicate his group to which he belongs or his original sex, and a telephone interview with the adolescent and with his parents where they will have been previously informed not to not reveal the group to which they belong or the sex of origin., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: hormonal treatment with cross sex hormones (testosterone or oestrogenes) started at 14 years old +/- 6 months, interventions name: Cross sex hormones ( œstrogenes or testosterone) started at 16 years old +/- 6 months, outcomesModule primaryOutcomes measure: Global functionning using the Children's Global Assessment Scale (CGAS), secondaryOutcomes measure: DEP-ADO, secondaryOutcomes measure: WISC-V (weschler Test), secondaryOutcomes measure: UGDS (Utrecht Gender Dysphoria Scale ), secondaryOutcomes measure: Beck Depression Inventory (BDI), secondaryOutcomes measure: Body Image Scale (BIS), secondaryOutcomes measure: State and Anxiety Inventory for Children (STAI-C), secondaryOutcomes measure: CBCL (Youth Self Report YSR) Child Behaviour Chekcklist, secondaryOutcomes measure: World Health Organization Quality Of Life (WHO QOL), secondaryOutcomes measure: Satisfaction With Life Scale (SWLS), secondaryOutcomes measure: Adolescent Depression Rating Scale (ADRS), secondaryOutcomes measure: Mini International Neuropsychiatric Interview (MINI), secondaryOutcomes measure: Inventory of Parents and Peers Attachment (IPPA), eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 14 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False