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Evaluation of the effectiveness of hormonal treatment in adolescents suffering from gender dysphoria
EU CTIS ID: 2024-513250-30-00
What this study is testing
To evaluate, in gender dysphoric adolescents, having completed their social transition, having or not undergone prior pubertal suppression, the effectiveness of hormonal treatment with estrogens or testosterone initiated at 13.5 years +/- 6 months of age on the overall functioning of the teenager at 15.5 years +/- 6 months old.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - Adolescents aged 13.5 years old (+/- 6 months)
- - Having initiated puberty: tanner score ≥2 for transgender boys; tanner score ≥2 (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 was 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.
You likely can't join if
- - Contraindication to experimental hormonal treatment (see paragraph 1.5)
- - 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 arterial hypertension.
- - Patients suffering from epilepsy and migraine.
- - Patients with existence or history of thromboembolic events.
See the full eligibility criteria
- - Adolescents aged 13.5 years old (+/- 6 months)
- - Having initiated puberty: tanner score ≥2 for transgender boys; tanner score ≥2 (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 was 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.
- - Contraindication to experimental hormonal treatment (see paragraph 1.5)
- - 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 arterial hypertension.
- - Patients suffering from epilepsy and migraine.
- - Patients with existence or history of thromboembolic events.
- - Severe untreated chronic depression clinically assessed and documented using the Beck Depression Inventory (BDI).
- - Insufficient knowledge of French
- - 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,
- - Diagnosed schizophrenia that is unstable or progressive
- - Diagnosed bipolar disorder that is unstable or progressive
- - 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.
- - Suicidal ideation identified through the MINI with a Columbia C-SSRS score > 4, until the clinical condition has stabilized
- - Refusal to participate in the study by the adolescent or one of the holders of parental authority (both holders and the adolescent must sign written consent after having received appropriate information).
- - No social security cover
- - Participation in another intervention research
- - Ongoing pregnancy
- - Need for adjustment of hormonal treatment (transgender boys patient treated with anticoagulants or having thrombophilia).
- - Patients with risk of worsening of certain diseases under estrogen treatment (transgender girls patients with uncontrolled diabetes with HBA1C > 8%, patients with cholelithiasis, biliary lithiasis, systemic lupus erythematosus, severe asthma, severe hypertension, severe migraines, otosclerosis, epilepsy not controlled by treatment.
- - Current anticoagulant treatment
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.