NCT06351501View on ClinicalTrials.gov

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

PHASE3RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

June 25, 2024

Primary Completion Date

June 24, 2029

Study Completion Date

June 24, 2031

Conditions
Gender Dysphoria
Interventions
DRUG

hormonal treatment with cross sex hormones (testosterone or oestrogenes) started at 14 years old +/- 6 months

4 years of follow up (FU) with evaluation at T0 (14 years old +/- 6 months), T1 (16 years old +/-6 months) and T2 (18 years old+/- 6 months) with eather ANDROGEL® 16.2 mg/g, gel (testostérone) or ESTREVA® 0.1 %, gel ou 1.3 PROVAMES® 1 mg, cp (oestrogenes)

DRUG

Cross sex hormones ( œstrogenes or testosterone) started at 16 years old +/- 6 months

2 years of hormonal treatment from 16 old +/- 6 months to 18 years old +/- 6 months

Trial Locations (4)

75013

RECRUITING

Service de psychiatrie de l'enfant et de l'adolescent, GH Pitié-Salpêtrière, Paris

75019

RECRUITING

Service d'Endocrinologie et Diabétologie Pédiatrique, CHU Robert Debré, Paris

RECRUITING

Service de Psychiatrie de l'enfant et de l'adolescent, CHU Robert Debré, Paris

94270

NOT_YET_RECRUITING

Service Endocrinologie et Diabète de l'enfant, CHU Le Kremlin Bicêtre, Le Kremlin-Bicêtre

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER