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Earlier hormone therapy: a lifeline for transgender teens?

NCT ID NCT06351501

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This trial looks at whether starting cross-sex hormones at age 13.5, rather than the usual 15.5, improves the well-being of adolescents with gender dysphoria. Participants will receive either testosterone or estrogen and be followed for four years. The study measures overall functioning, anxiety, depression, and quality of life to see if earlier treatment reduces distress and supports healthier development.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cross-sex hormones (testosterone or estrogen) given as gel or tablets
What this could lead to
If starting hormones earlier improves mental health and daily functioning, it could support earlier access to gender-affirming care for transgender teens.
What could go wrong
This is a relatively small trial, and results may not apply to all teens. Hormonal treatment carries potential side effects, and the benefit of earlier start is not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Jun 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

156 to 168 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adolescents aged 13.5 years +/- 6 months, * Having initiated puberty: tanner score ≥2 for transgender boys; tanner score ≥2 for ; (clinic and/or testosterone \>0.3 ng/mL) for transgender girls * 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. Exclusion Criteria: * Contraindication to hormonal treatment (see paragraph 1.5) * Hormonal treatment needs to be adjusted (transgender boys patients treated with anti-coagulants or with thrombophilia). * Patients with risk of aggravation of certain diseases under oestrogen treatment (transgender girls 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 clinically assessed and documented using the Beck Depression Inventory (BDI). * Diagnosed schizophrenia that is unstable or progressive * Diagnosed bipolar disorder that is unstable or progressive * Suicidal ideation identified through the MINI with a Columbia C-SSRS score \> 4, until the clinical condition has stabilized * 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

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Conditions

The condition(s) this trial relates to.

Gender Dysphoria Psychological Well-Being

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    NOT_YET_RECRUITING

    Le Kremlin-Bicêtre, Île-de-France Region, 94270, France

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

    RECRUITING

    Paris, 75019, France

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

    RECRUITING

    Paris, 75019, France

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

    RECRUITING

    Paris, 75013, France

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