Evaluation of the Effectiveness of Hormonal Treatment in Adolescents Suffering From Gender Dysphoria
Recruiting
Phase 3Interventional Study
Gender Dysphoria
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
156 Months – 168 Months
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Assistance Publique - Hôpitaux de Paris · Other
Who this trial is looking for
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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 be…
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.
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Eligibility 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 …
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
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