2024-513250-30-00招募中3 期
TRANSADO - Evaluation of the effectiveness of hormonal treatment in adolescents suffering from gender dysphoria
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary outcome measure is the adolescent's global functioning as assessed by the Children's Global Assessment Scale (CGAS) at age 16 years old +/- 6 months.
研究概览
简要总结
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 14 years +/- 6 months of age on the overall functioning of the teenager at 16 years +/- 6 months old.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Prospective Open Blinding Endpoint PROBE study
- 盲法
- Single (Analyst, Carer)
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Adolescents aged 14 years old (+/- 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 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.
排除标准
- •Contraindication to experimental hormonal treatment (see paragraph 1.5)
- •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 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 (FtM patient treated with anticoagulants or having thrombophilia).
- •Patients with risk of worsening of certain diseases under estrogen treatment (MtF 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
- •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.
- •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,
结局指标
主要结局
The primary outcome measure is the adolescent's global functioning as assessed by the Children's Global Assessment Scale (CGAS) at age 16 years old +/- 6 months.
The primary outcome measure is the adolescent's global functioning as assessed by the Children's Global Assessment Scale (CGAS) at age 16 years old +/- 6 months.
次要结局
- - Global Assesment Scale (GAS) at T2.
- - Weschler scale (WISC V) at T0 et T2,
- - The Gender Identity/ Gender Dysphoria Questionnaire for Adolescents and Adults scale (GIDYQ-AA) and the Utrecht Gender Dysphoria Scale (UGDS) at selection visit, T1 et T2,
- - Beck Depression Inventory (BDI) scale at T0, T1 et T2,
- - Body Image Scale (BIS) scale at T0, T1 et T2,
- - State-Trait Anxiety Inventory for Children (STAIC) scale at T0, T1 et T2,
- - Child Behaviour Checklist (CBCL) scale at T0, T1 et T2,
- - MINI International Neuropsychiatric Interview (MINI) at selection visit, T1 et T2
- - Youth Self Report (YSR) scale at T0, T1 et T2,
- - World Health Organization Quality Of Life - BREF (WHOQOL-BREF) scale at T0, T1 et T2,
- - Satisfaction With Life Scale (SWLS) at T0, T1 et T2.
- - Height, bone mineral density, BMI, waist to hip ratio at inclusion visit, T1 et T2.
- - Potential side-effects at T0, T1 et T2.
- - The emotional and sexual relationship: assessed by specific questions at T0, T1 et T2
- - Drug use: assessed by specific questions via the DEP-ADO questionnaire (screening grid for problem substance use among adolescents) at T0, T1 and T2
- - School drop-out / family breakdown: assessed by specific questions at T0, T1 et T2
- Psycho-affective criteria will be assessed by a psychologist trained in the relevant assessment scales, while somatic criteria will be collected by the pediatric endocrinologist.
研究者
Pr David Cohen
Scientific
Assistance Publique Hopitaux De Paris
研究点 (1)
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