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

Condition(s) studied

Investigational drug(s) / intervention(s)

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 (13.5 years old +/- 6 months), T1 (15.5 years old +/-6 months) and T2 (17.5 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)

Cross sex hormones ( œstrogenes or testosterone) started at 15.5 years old +/- 6 months: 2 years of hormonal treatment from 15.5 old +/- 6 months to 17.5 years old +/- 6 months

Study summary

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.

Eligibility

Primary outcome measure(s)

• Global functionning using the Children's Global Assessment Scale (CGAS) — 15.5 years old +/- 6 months
  The Children's Global Assessment Scale (CGAS), adapted from the Global Assessment Scale for adults, is a rating of general functioning for children and young people until 16 years old. The clinician assesses a range of aspects of psychological and social functioning and gives the child or young person a single score between 1 and 100, based on their lowest level of functioning. The score puts them in one of ten categories that range from "needs constant supervision" (1-10) to "superior functioning" (91-100). The measure can be used by clinicians as well as researchers to complement other scales measuring more specific symptoms.

Trial sites (4)

More Assistance Publique - Hôpitaux de Paris trials in France

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