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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Apr 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of starting hormonal treatment earlier in adolescents who experience gender dysphoria, a condition where a person feels a mismatch between their gender identity and the sex they were assigned at birth. The trial aims to see if beginning hormonal transition at around age 14, instead of waiting until age 16, can help reduce problems like anxiety, depression, and other challenges these adolescents face. By providing earlier access to treatment, the hope is to improve their overall well-being and quality of life.

To be eligible for this study, participants must be between the ages of 14 and 16 and have begun puberty. They need to have been diagnosed with gender dysphoria by mental health professionals during at least two separate evaluations. Additionally, their need for hormonal treatment must be confirmed by a team of medical experts. If a participant joins the study, they can expect to receive support and monitoring from healthcare professionals throughout the process. It's important to know that certain medical conditions may disqualify someone from participating, and both the adolescent and their guardians will need to give consent to join the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adolescents aged 14+/- 6 months,
• • Having initiated puberty: tanner score ≥2 for FtM; tanner score ≥2 (clinic and/or testosterone \>0.3 ng/mL) for MtF
• • 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 (FtM patients treated with anti-coagulants or with thrombophilia).
• • Patients with risk of aggravation of certain diseases under oestrogen treatment (MtF 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
• • 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