Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT06351501 En recrutement IDF

Titre

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

Type

Interventional

Pathologie

Dysphorie de genre
Trouble dépressif majeur

Phase

Phase 3

Promoteur

Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)

Date de début

juin 2024

Date de fin

juin 2031

Dernière mise à jour

29 août 2025

Résumé

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 16. However, in order to reduce the psychosocial consequences of GD, more and more referral teams are carrying out this transition from the age of 14, although no study has been published to show its benefit compared with a transition at the age of 16. 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.

Détail

Voir le détail Multicenter, controlled, randomized, open trial with blinded evaluation of the primary endpoint (Prospective Open Blinding Endpoint PROBE study). Randomization will be stratified by sex assigned at birth and the investigating center. The primary analysis will be intention-to-treat and multiple imputation methods will be used to handle missing data. After verification of the inclusion criteria by the child psychiatrist (selection visit), then the pediatric endocrinologist (inclusion visit), the adolescent will be included in the study and will benefit from an initial evaluation (T0) by a psychologist trained for the primary criterion (CGAS) and secondary psycho-affective criteria.The patients will then be sent again to the pediatric endocrinologist who will randomize the patient (via an IT platform) and give them the treatment corresponding to their assigned group. Adolescents in both groups will be reassessed at 16 years +/- 6 months (T1). At the end of this evaluation, patients in the control group will begin their hormonal treatment. Adolescents will undergo a final evaluation at 18 years +/- 6 months (T2), at which time the same criteria as at T0 and T1 will be collected. Main objective: 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. Primary endpoint: Children's Global Assesment Scale (CGAS) score at age 16 +/- 6 months Secondary objectives : Evaluate, in gender dysphoric adolescents who have completed their social transition, whether or not they have benefited from prior pubertal suppression: - the effectiveness of hormonal treatment started at 14 years old +/- 6 months vs. 16 years old +/- 6 months on the overall functioning of the adolescent at 18 years old+/- 6 months, - the safety (side effects) of hormonal treatment started at age 14 +/- 6 months, - and the relevance of hormonal treatment started at 14 years old +/- 6 months on other parameters assessed at 16 +/- 6 months and 18 +/- 6 months years old (gender identity, depression, anxiety, emotional, behavioral disorders and other comorbidities, objective and subjective quality of life, body image, height, waist/hip ratio, bone mineral density, BMI). Fermer le détail

Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
CIAPA POUR ADOLESCENTS SIMPLON	COHEN David	En recrutement IDF	01/11/2025 08:16:07	Contacter
AP-HP Assistance publique - Hôpitaux de Paris		En recrutement IDF	01/11/2025 08:16:08	Contacter
	AP-HP - Hôpital Bicêtre
	AP-HP - Hôpital La Pitié-Salpêtrière
	AP-HP - Hôpital Robert Debré
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Service de Psychiatrie de l'enfant et de l'adolescent, CHU Robert Debré - 75019 - Paris - France	Alexandre Michel	En recrutement		Contact (sur clinicalTrials)
Service de psychiatrie de l'enfant et de l'adolescent, GH Pitié-Salpêtrière - 75013 - Paris - France	David Cohen	En recrutement		Contact (sur clinicalTrials)
Service d'Endocrinologie et Diabétologie Pédiatrique, CHU Robert Debré - 75019 - Paris - France	Laetitia Martinerie	En recrutement		Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

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.

Critère de non inclusion

- 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

NCT06351501 - Evaluation of the Effectiveness of Hormonal Treatment in Adolescents Suffering from Gender Dysphoria

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