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Evaluation of the Effectiveness of Hormonal Treatment in Adolescents Suffering From Gender Dysphoria

Study acronym: TRANSADO
StatusRecruiting
PhasePhase 3
Started2024-06-25
View on ClinicalTrials.gov ↗

Amendment history

2026-08-05
Study Identification, Study Status, Oversight, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v2
InterventionsCross sex hormones ( œstrogenes or testosterone) started at 16 years old +/- 6 months (Drug), hormonal treatment with cross sex hormones…→Cross sex hormones ( œstrogenes or testosterone) started at 15.5 years old +/- 6 months (Drug), hormonal treatment with cross sex hormones…
Eligibility criteria+386 characters
Inclusion Criteria: Adolescents aged 1413.5 years +/- 6 months, Having initiated puberty: tanner score ≥2 for FtMtransgender boys; tanner score ≥2 for ; (clinic and/or testosterone >0.3 ng/mL) for MtFtransgender girls Presenting the criteria for gender dysphoria according to t [...] see paragraph 1.5) Hormonal treatment needs to be adjusted (FtMtransgender boys patients treated with anti-coagulants or with thrombophilia [...] aggravation of certain diseases under oestrogen treatment (MtFtransgender girls patients with uncontrolled diabetes with HBA1C > 8%, patien [...] f thromboembolic events. Severe untreated ch [...]
Secondary endpoints16 to 17 entries
Suicidal risk
Study description+24 characters
[...] ned group. Adolescents in both groups will be reassessed at 1615.5 years +/- 6 months (T1). At the end of this evaluation, pat [...] l treatment. Adolescents will undergo a final evaluation at 1817.5 years +/- 6 months (T2), at which time the same criteria as [...] monal treatment with estrogens or testosterone initiated at 1413.5 years +/- 6 months of age on the overall functioning of the teenager at 1615.5 years +/- 6 months old. Primary endpoint: Children's Global Assesment Scale (CGAS) score at age 1615.5 +/- 6 months Secondary objectives : Evaluate, in gender dys [...] ression: the effectiveness of hormonal t [...]
Study sitesdetails revised at 3 of 4 sites
Study titlerevised
Evaluation of the Effectiveness of Hormonal Treatment in Adolescents Suffering fromFrom Gender Dysphoria
2025-03-10
Not Yet Recruiting→Recruiting Study Identification, Study Status, Oversight, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2029-06-06→2029-06-24
Completion date2031-06-06→2031-06-24
Start dateestimated 2024-06-06→confirmed 2024-06-25
Study sites0→4
Eligibility criteria-82 characters
Inclusion Criteria: Adolescents aged 14+/- 6 months, Having initiated puberty: Tannertanner score ≥2 for FtM; tanner score ≥2 (clinic and/or testosterone >0.3ng3 ng/mL) for MtF presentingPresenting the criteria for gender dysphoria according to the DSM5 ass [...] ysphoria Questionnaire for Adults and Adolescents (GIDYQ-AA), and Recalled ChildhoodUtrecht Gender IdentityDysphoria Scale (UGDS),) whoseWhose indication for hormonal transition has been validated in a [...] nts in the context of gender dysphoria. Exclusion Criteria: contraindicationContraindication to experimental hormonal treatment (see paragrap [...] [...]
Secondary endpoints12 to 16 entries
Drug use (DEP-ADO) UGDS (Utrecht Gender Dysphoria Scale ) CBCL and GIDYQ-AA (YouthGender SelfIdentity/ ReportGender YSRDysphoria Questionnaire for Adolescents and Adults scale ) Child Behaviour Chekcklist World Health Organization Quality Of Life - BREF (WHO QOLWHOQOL-BREF) AdolescentHeight, Depressionbone Ratingmineral density, BMI, waist to hip ratio The emotional and sexual relationship School drop-out / family breakdown Global Assesment Scale (ADRSGAS) InventoryPotential ofside-effects Child ParentsBehaviour and Peers AttachmentChecklist (IPPACBCL) scale Youth Self Report (YSR) scale
Study description+283 characters
This study is a multicenteredMulticenter, controlled, randomized, open trial with blinded assessmentevaluation of the primary outcome measureendpoint (Prospective Open Blinding Endpoint PROBE study). Randomiza [...] by sex assigned at birth and the investigating center. The mainprimary analysis will be intention-to-treat and multiple imputation methods will be used to handle missing data. OnceAfter verification of the inclusion criteria are checked by the child psychiatrist (selection visit), andthen the pediatric endocrinologist (inclusion visit), the adolescent will be included in the study withan [...] [...]
Study titlerevised
Evaluation of the Effectiveness of Hormonal Treatment in Adolescents Suffering Fromfrom Gender Dysphoria
2024-04-02
Original filing
Gender dysphoria (GD) is a significant suffering lasting more than 6 months in a subject, with regard to the discrepancy felt between his or her gender identity and his or her birth sex. From the onset of puberty, most of these self-identified transgender adolescents will persist in their transgender identity and will undergo hormonal and surgical reassignment when the time comes. International best practice guidelines recommend early treatment from the start of pubertal development to block pubertal progression, with the possibility of hormonal transition by administering sex hormones of the desired sex usually around the age of 15.5. However, in order to reduce the psychosocial consequences of GD, more and more referral teams are carrying out this transition from the age of 13.5, although no study has been published to show its benefit compared with a transition at the age of 15.5. In the absence of treatment, co-morbidity among adolescents suffering from gender dysphoria is very high, with anxiety-depressive states, suicidal risk and dropping out of school in the forefront. Our hypothesis is that hormonal transition started at an age closer to physiological puberty can significantly reduce this comorbidity and improve quality of life for these adolescents. This is the first therapeutic trial to be conducted in France in the transgender adolescent population, in an area where international recommendations based on the principles of Evidence Based Medicine are essentially derived from the clinical expertise of teams who have specialized in the care of transgender people for over forty years, while clinical data derived from structured research are still very scarce. The results of this study will guide the care of transgender adolescents, allowing them, if the study is positive, to access hormonal treatments earlier and thus more quickly improve their overall functioning, anxiety-depressive symptoms and their quality of life.
Trial Details
NCT Number NCT06351501
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Conditions Gender Dysphoria
Enrollment 60 participants
Start Date 2024-06-25
Primary Completion 2029-06-24 (estimated)
Study Completion 2031-06-24 (estimated)
Updated on ClinicalTrials.gov 2026-08-10