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
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Gender dysphoria causes significant distress in adolescents who feel a mismatch between their gender identity and birth sex, often lasting more than six months. Most transgender adolescents continue to identify as transgender from puberty onset and may undergo hormonal and surgical transitions. This research investigates whether starting hormonal treatment earlier, around age 14, compared to the usual age of 16, can reduce psychological difficulties and improve quality of life. The trial is a controlled, randomized, open study with blinded evaluation, conducted to provide structured clinical data in this area. Participants are randomly assigned to one of two groups: one receiving early hormonal treatment starting at about 14 years old, combined with usual care, and the other receiving usual care with hormonal treatment starting at about 16 years old. Usual care includes psychiatric, endocrinological, and psychological consultations along with family and local support. Hormonal treatments include testosterone or estrogen gels or tablets, with follow-up evaluations at ages 14, 16, and 18. Throughout the study, adolescents undergo psychological assessments, including measures of overall functioning, depression, anxiety, body image, quality of life, and cognitive testing, as well as physical evaluations like height, bone density, and BMI. Researchers monitor side effects and other health parameters at regular intervals. The primary outcome is overall functioning at age 16, with further assessments at age 18 to evaluate long-term effects and safety. The total participation period is about four years, with regular visits and evaluations.
CONDITIONS
Brief 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 with Tanner score 2 or higher (FtM or MtF criteria)
- Diagnosed with gender dysphoria according to DSM-5 by at least two child psychiatric interviews spaced six months apart
- Have completed social transition
- Hormonal transition indication validated by a multidisciplinary consultation including pediatric endocrinologist examination
- Provide written consent from adolescent and holders of parental authority
- Have social security coverage
You will not qualify if you...
- Contraindication to hormonal treatment
- Need for hormonal adjustment in FtM patients treated with anticoagulants or with thrombophilia
- Risk of disease worsening under estrogen treatment (uncontrolled diabetes with HbA1C >8%, cholelithiasis, lupus, severe asthma, severe hypertension, severe migraines, otosclerosis, uncontrolled epilepsy)
- Cancer with risk of hypercalcemia linked to bone metastases
- Severe cardiac, liver, or kidney failure or ischemic heart disease
- Uncontrolled high blood pressure
- Epilepsy and migraine
- Current or history of thromboembolic events
- Severe untreated chronic depression
- Current anticoagulant treatment
- Severe autism spectrum disorder confirmed by clinical screening and Social Responsiveness Scale
- Cognitive deficit with IQ below 80 confirmed by 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 language
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Selection visit with child psychiatrist, followed by inclusion visit with pediatric endocrinologist
Duration - 2 to 4 years depending on group assignment
Participants receive hormonal treatment with cross sex hormones (testosterone or estrogens) started at either 14 years old +/- 6 months or 16 years old +/- 6 months depending on randomization.
Initial treatment visit and follow-up evaluations at ages 16 and 18 years +/- 6 months
Duration - Up to 4 years from enrollment
Participants are evaluated on overall functioning, psychological, physical, and quality of life parameters at 16 and 18 years old +/- 6 months including monitoring for potential side effects.
2 follow-up visits at approximately ages 16 and 18 years
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
A
Anne BISSERY
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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