Evaluating hormonal treatment for adolescents with gender dysphoria
Official title: Evaluation of the Effectiveness of Hormonal Treatment in Adolescents Suffering From Gender Dysphoria
Run by Assistance Publique - Hôpitaux de Paris · NCT06351501 · Data updated 2026-11-12
This study tests if giving cross-sex hormones to teens with gender dysphoria who have started their social transition helps them feel better and function well compared to those who don’t receive the hormones.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 156 Months to 168 Months |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 4 sites (Paris and 3 other locations) |
| Status | Recruiting |
| Started | June 25, 2024 |
| Main results expected | June 24, 2029 |
| Study ends | June 24, 2031 |
| Registry record updated | August 10, 2026 |
| Trial ID | NCT06351501 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adolescents aged 14 years who have been diagnosed with gender dysphoria and have initiated puberty.
✕Probably not a fit
Patients who do not meet the inclusion criteria, such as those with contraindications to hormonal treatment or those not diagnosed with gender dysphoria, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of hormonal treatment in adolescents diagnosed with gender dysphoria, focusing on those who have completed their social transition. The study is a multicenter, controlled, randomized trial that includes a blinded evaluation of outcomes. Adolescents aged 14 years will be randomized to receive either cross-sex hormones (testosterone or estrogen) or a control treatment, with assessments conducted at ages 16 and 18 to evaluate overall functioning and psychosocial outcomes. The trial aims to provide evidence on the benefits of early hormonal intervention compared to later treatment.
Why it matters
Potential benefit: If successful, this study could provide critical evidence supporting early hormonal treatment for adolescents with gender dysphoria, potentially improving their mental health and overall quality of life.
How similar studies have gone: While there is a growing body of literature on hormonal treatments for gender dysphoria, this specific approach of early intervention at age 14 is novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adolescents aged 13.5 years +/- 6 months, * Having initiated puberty: tanner score ≥2 for transgender boys; tanner score ≥2 for ; (clinic and/or testosterone \>0.3 ng/mL) for transgender girls * Presenting the criteria for gender dysphoria according to the DSM5 assessed by at least two child psychiatric interviews at least six months apart where the diagnosis of gender dysphoria was clinically established and that of associated autism spectrum disorder refuted and/or associated cognitive impairment, confirmed by specific scales (Gender Identity / Gender Dysphoria Questionnaire for Adults and Adolescents (GIDYQ-AA) and Utrecht Gender Dysphoria Scale (UGDS)) * Whose indication for hormonal transition has been validated in a multidisciplinary consultation meeting after at least one consultation with the pediatric endocrinologist with clinical examination, blood pressure measurement, and information on hormonal treatments in the context of gender dysphoria. Exclusion Criteria: * Contraindication to hormonal treatment (see paragraph 1.5) * Hormonal treatment needs to be adjusted (transgender boys patients treated with anti-coagulants or with thrombophilia). * Patients with risk of aggravation of certain diseases under oestrogen treatment (transgender girls patients with uncontrolled diabetes with HBA1C \> 8%, patients with cholelithiasis, biliary lithiasis, systemic lupus erythematosus, severe asthma, severe arterial hypertension, severe migraines, otosclerosis, epilepsy not controlled by treatment). * Patients with cancer with a risk of hypercalcemia (and associated hypercalciuria), linked to bone metastases. * Severe cardiac, hepatic or renal failure or ischemic heart disease, due to the risk of severe complications characterized by edema, with or without congestive heart failure. * Uncontrolled high blood pressure. * Patients with epilepsy and migraine. * Patients with current or history of thromboembolic events. * Severe untreated chronic depression clinically assessed and documented using the Beck Depression Inventory (BDI). * Diagnosed schizophrenia that is unstable or progressive * Diagnosed bipolar disorder that is unstable or progressive * Suicidal ideation identified through the MINI with a Columbia C-SSRS score \> 4, until the clinical condition has stabilized * Current anticoagulant treatment * Severe autism Spectrum Disorder (clinical screening, confirmed in cases of doubt by the Social Responsiveness Scale (SRS) Raw-score \> 76, carried out as part of usual care in cases of clinical evidence, * Cognitive deficit (clinical screening, confirmed by an QI \< 80 on the Weschler scale (WISC V), carried out as part of the usual treatment in the event of clinical evidence. * Refusal to participate in the study on the part of the adolescent or one of the holders of parental authority (both holders and the adolescent must sign a written consent after receiving appropriate information). * No social security cover * Participation in other intervention research * Pregnancy in progress * Insufficient knowledge of French
Where it's running
-
Service de psychiatrie de l'enfant et de l'adolescent, GH Pitié-Salpêtrière
Paris, France Recruiting -
Service d'Endocrinologie et Diabétologie Pédiatrique, CHU Robert Debré
Paris, France Recruiting -
Service de Psychiatrie de l'enfant et de l'adolescent, CHU Robert Debré
Paris, France Recruiting -
Service Endocrinologie et Diabète de l'enfant, CHU Le Kremlin Bicêtre
Le Kremlin-Bicêtre, Île-de-France Region, France Not yet recruiting
Study contacts
- Study coordinator: David COHEN, MD,PhD
- Email: david.cohen@aphp.fr
- Phone: 01 42 16 23 51
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.