Actively Recruiting
Evaluation of the Effectiveness of Hormonal Treatment in Adolescents Suffering from Gender Dysphoria
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-03-13
60
Participants Needed
4
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of the Effectiveness of Hormonal Treatment in Adolescents Suffering from Gender Dysphoria
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adolescents aged 14 years plus or minus 6 months
- Have started puberty: Tanner score 62 for female-to-male; Tanner score 62 (clinical and/or testosterone >0.3 ng/mL) for male-to-female
- Meet criteria for gender dysphoria per DSM5 confirmed by two child psychiatric interviews at least six months apart and confirmed by specific scales
- Indication for hormonal transition validated in a multidisciplinary consultation after at least one pediatric endocrinologist consultation including clinical exam, blood pressure, and hormonal treatment information
You will not qualify if you...
- Contraindication to hormonal treatment
- Need to adjust hormonal treatment for FtM patients treated with anticoagulants or with thrombophilia
- Risk of worsening certain diseases under estrogen treatment such as uncontrolled diabetes with HbA1C >8%, gallstones, lupus, severe asthma, severe hypertension, severe migraines, otosclerosis, uncontrolled epilepsy
- Cancer with risk of hypercalcemia related to bone metastases
- Severe cardiac, liver, or kidney failure or ischemic heart disease
- Uncontrolled high blood pressure
- History or current thromboembolic events
- Severe untreated chronic depression
- Current anticoagulant treatment
- Severe autism spectrum disorder confirmed by clinical screening and Social Responsiveness Scale
- Cognitive deficit confirmed by clinical screening and IQ <80 on Weschler scale
- Refusal to participate by adolescent or parental authority
- No social security coverage
- Participation in other intervention research
- Current pregnancy
- Insufficient knowledge of French
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Trial Site Locations
Total: 4 locations
1
Service de psychiatrie de l'enfant et de l'adolescent, GH Pitié-Salpêtrière
Paris, Paris, France, 75013
Actively Recruiting
2
Service d'Endocrinologie et Diabétologie Pédiatrique, CHU Robert Debré
Paris, Paris, France, 75019
Actively Recruiting
3
Service de Psychiatrie de l'enfant et de l'adolescent, CHU Robert Debré
Paris, Paris, France, 75019
Actively Recruiting
4
Service Endocrinologie et Diabète de l'enfant, CHU Le Kremlin Bicêtre
Le Kremlin-Bicêtre, Île-de-France Region, France, 94270
Not Yet Recruiting
Research Team
D
David COHEN, MD,PhD
CONTACT
A
Anne BISSERY
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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