Gender DysphoriaPhase 3TRANSADONCT06351501
Evaluation of the Effectiveness of Hormonal Treatment in Adolescents Suffering From Gender Dysphoria
A Phase 3 study testing hormonal treatment with cross sex hormones (testosterone or oestrogenes) started at 14 years old +/- 6 months and Cross sex hormones ( œstrogenes or testosterone) started at 15.5 years old +/- 6 months in people with Gender Dysphoria, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 156 to 168 months
- Conditions the study is for
- Gender Dysphoria
- What is being tested?
- hormonal treatment with cross sex hormones (testosterone or oestrogenes) started at 14 years old +/- 6 months and Cross sex hormones ( œstrogenes or testosterone) started at 15.5 years old +/- 6 months
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesFrance
- Study dates
- 25 Jun 2024to 24 Jun 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 156 to 168 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Not yet recruiting
Service Endocrinologie et Diabète de l'enfant, CHU Le Kremlin Bicêtre
Le Kremlin-Bicêtre, Île-de-France Region, 94270
Marie-Agathe Trouvin, +33 0145217291, marieagathe.trouvin@aphp.fr
Anne-Sophie Lambert, anne-sophie.lambert@aphp.fr
- Recruiting
Service de psychiatrie de l'enfant et de l'adolescent, GH Pitié-Salpêtrière
Paris, 75013
David Cohen, +33 0142162351, david.cohen@aphp.fr
Julie Brunelle, julie.brunelle@aphp.fr
- Recruiting
Service d'Endocrinologie et Diabétologie Pédiatrique, CHU Robert Debré
Paris, 75019
Laetitia Martinerie, +33 0140035303, laetitia.martinerie@aphp.fr
- Recruiting
Service de Psychiatrie de l'enfant et de l'adolescent, CHU Robert Debré
Paris, 75019
Alexandre Michel, +33 0187275105, alexandre.michel@aphp.fr
About this study
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.
Read the detailed description
Multicenter, controlled, randomized, open trial with blinded evaluation of the primary endpoint (Prospective Open Blinding Endpoint PROBE study). Randomization will be stratified by sex assigned at birth and the investigating center. The primary analysis will be intention-to-treat and multiple imputation methods will be used to handle missing data. After verification of the inclusion criteria by the child psychiatrist (selection visit), then the pediatric endocrinologist (inclusion visit), the adolescent will be included in the study and will benefit from an initial evaluation (T0) by a psychologist trained for the primary criterion (CGAS) and secondary psycho-affective criteria.The patients will then be sent again to the pediatric endocrinologist who will randomize the patient (via an IT platform) and give them the treatment corresponding to their assigned group. Adolescents in both groups will be reassessed at 15.5 years +/- 6 months (T1). At the end of this evaluation, patients in the control group will begin their hormonal treatment. Adolescents will undergo a final evaluation at 17.5 years +/- 6 months (T2), at which time the same criteria as at T0 and T1 will be collected.
Main objective: To evaluate, in gender dysphoric adolescents, having completed their social transition, having or not undergone prior pubertal suppression, the effectiveness of hormonal treatment with estrogens or testosterone initiated at 13.5 years +/- 6 months of age on the overall functioning of the teenager at 15.5 years +/- 6 months old.
Primary endpoint: Children's Global Assesment Scale (CGAS) score at age 15.5 +/- 6 months
Secondary objectives : Evaluate, in gender dysphoric adolescents who have completed their social transition, whether or not they have benefited from prior pubertal suppression:
- the effectiveness of hormonal treatment started at 13.5 years old +/- 6 months vs. 15.5 years old +/- 6 months on the overall functioning of the adolescent at 17.5 years old+/- 6 months,
- the safety (side effects) of hormonal treatment started at age 13.5 +/- 6 months,
- and the relevance of hormonal treatment started at 13.5 years old +/- 6 months on other parameters assessed at 15.5 +/- 6 months and 17.5 +/- 6 months years old (gender identity, depression, anxiety, emotional, behavioral disorders and other comorbidities, objective and subjective quality of life, body image, height, waist/hip ratio, bone mineral density, BMI).
- Conditions
- Gender Dysphoria
- Being tested
- hormonal treatment with cross sex hormones (testosterone or oestrogenes) started at 14 years old +/- 6 months, Cross sex hormones ( œstrogenes or testosterone) started at 15.5 years old +/- 6 months
- Keywords
- Gender Dysphoria, adolescents, hormonal treatment, mental health
- Medical subject headings
- Gender Dysphoria, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hormonal treatment with cross sex hormones (testosterone or oestrogenes) started at 14 years old +/- 6 monthsDrug
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 monthsDrug
2 years of hormonal treatment from 15.5 old +/- 6 months to 17.5 years old +/- 6 months
| Study group | Role | What they receive |
|---|---|---|
| early hormonal treatment | Experimental | early hormonal treatment initiated at 13.5 years +/- 6 months, in addition to usual care Receives: Drug: hormonal treatment with cross sex hormones (testosterone or oestrogenes) started at 14 years old +/- 6 months |
| usual treatment | Active comparator | Usual care between 13.5 and 15.5 years +/- 6 months : child psychiatric consultations, endocrinological consultations and consultations with a psychologist, family interviews, network work with local health partners and national education.
Then hormonal treatment initiated at 15.5 years +/- 6 months, in addition to usual care. Receives: Drug: Cross sex hormones ( œstrogenes or testosterone) started at 15.5 years old +/- 6 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global functionning using the Children's Global Assessment Scale (CGAS)
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.
Measured: 15.5 years old +/- 6 months
Secondary outcomes (17)
Drug use (DEP-ADO)
Drug use: assessed by specific questions via the DEP-ADO questionnaire (screening grid for problem substance use among adolescents).
Dep-Ado is a 15 minutes questionnaire to evaluate alcohol and substance use adolescent population aged 12 to 17 years. No problem if total score <12; warning of >12 et <19; pathological use needing intervention if >20
Measured: T0 (13.5 years old +/-6 months); T1 (15.5 years old+/-6 months); T2 ( 17.5 years old +/-6 months)
WISC-V (weschler Test)
cognitive test with 4 subscales (verbal comprehension index, perceptual reasoning index, logical score, working memory index, processing speed index). IQ is calculated. If <80, it is an non inclusion criteria. Normal range between 80 and 120. when > 120 précocity
Measured: T0 (13.5 years old +/-6 months); T2 ( 17.5 years old +/-6 months)
UGDS (Utrecht Gender Dysphoria Scale ) and GIDYQ-AA (Gender Identity/ Gender Dysphoria Questionnaire for Adolescents and Adults scale )
The Utrecht Gender Dysphoria Scale (UGDS) is a validated, 12-item screening measure for both adults and adolescents used extensively in gender clinics to assess gender dysphoria. Minimal score= 12; max=60. two versions (AFAB, AMAB)
Measured: selection visit ; T1 (15.5 years old +/-6 months) ; T2 (17.5 years old +/-6 months)
Beck Depression Inventory (BDI)
is a 21-question multiple-choice self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression.Min = 0 Max = 39 Between 0 and 3 = no Dépression
Measured: T0 (13.5 years old +/-6 mois); T1 (15.5 years old+/-6 monhs); T2 ( 17.5 years old +/-6 months)
Body Image Scale (BIS)
The 10-item BIS was developed to assess changes in body image assessed with a four-point scale from "not at all" to "very much." High scores indicate higher body image.(Min=30, Max=150 )
Measured: T0 (13.5 years old +/-6 months); T1 (15.5 years old+/-6 months); T2 ( 17.5 years old +/-6 months)
State and Anxiety Inventory for Children (STAI-C)
STAI-C includes 20-items that describe anxiety experiences a person might experience (e.g., item 6-"I worry too much"©). For each item, participants choose one of three options that indicate how often they experience the described situation - "hardly-ever", "sometimes" or "often"; these options are scored with 1, 2, and 3 points, respectively (total score range: 20-60). Higher scores indicate higher anxiety
Measured: T0 (13.5 years old +/-6 mois); T1 (15.5 years old+/-6 monhs); T2 ( 17.5 years old +/-6 months)
World Health Organization Quality Of Life - BREF (WHOQOL-BREF)
This 26-item instrument measures four fields, i.e. physical health, mental health, social relations and the environment. The analysis is based on the scores generated for each field (no overall score can be calculated). The user manual is comprehensive, which makes the instrument easy to use (WHO, 1996). While some studies call into question the construct validity (D'Abundo et al., 2011), the WHOQOL-BREF is generally recognized as a reliable, valid instrument to assess quality of life and is widely used in the literature for clinical and population-based surveys (Oliveira, Carvalho and Esteves, 2016; Skevington, Lotfy and O'Connell, 2004).
Measured: T0 (13.5 years old +/-6 months); T1 (15.5 years old+/-6 months); T2 ( 17.5 years old +/-6 months)
Satisfaction With Life Scale (SWLS)
The SWLS is a short 5-item instrument designed to measure global cognitive judgments of satisfaction with one's life. The scale usually requires only about one minute of a respondent's time.Min=5, Max=35. The higher score means a greater satisfaction with life
Measured: T0 (13.5 years old +/-6 months); T1 (15.5 years old+/-6 months); T2 ( 17.5 years old +/-6 months)
Height, bone mineral density, BMI, waist to hip ratio
MI is a measurement of a person's leanness or corpulence based on their height and weight, and is intended to quantify tissue mass
Measured: inclusion visit (13.5 years old +/-6 months); T1 (15.5 years old+/-6 months); T2 ( 17.5 years old +/-6 months)
Mini International Neuropsychiatric Interview (MINI)
To assess the 17 most common psychiatric disorders and suicidality in DSM-III-R, DSM-IV and DSM-5 and ICD-10. The MINI was designed as a brief structured diagnostic interview to meet the need for a short but accurate structured psychiatric interview for multicenter clinical trials and epidemiology studies and to be used as a first step in outcome tracking in nonresearch clinical settings.
Measured: selection visit ; T1 (15.5 years old+/-6 months); T2 ( 17.5 years old +/-6 months)
The emotional and sexual relationship
The emotional and sexual relationship assessed by specific questions
Measured: T0 (13.5 years old +/-6 months); T1 (15.5 years old+/-6 months); T2 ( 17.5 years old +/-6 months)
School drop-out / family breakdown
School drop-out / family breakdown assessed by specific questions
Measured: T0 (13.5 years old +/-6 months); T1 (15.5 years old+/-6 months); T2 ( 17.5 years old +/-6 months)
Global Assesment Scale (GAS)
assess the adolescent's overall functioning, heteroquestionnaire, score from 1 to 100, on file and after 30-minute interview
Measured: T2 : 17.5 years old +/-6 months
Potential side-effects
Measured: T0 (13.5 years old +/-6 months); T1 (15.5 years old+/-6 months); T2 ( 17.5 years old +/-6 months)
Child Behaviour Checklist (CBCL) scale
Emotional disorders and possible comorbidities assessed by the Child Behavior Checklist (CBCL) score, parent self-questionnaire, 15 minutes
Measured: T0 (13.5 years old +/-6 months); T1 (15.5 years old+/-6 months); T2 ( 17.5 years old +/-6 months)
Youth Self Report (YSR) scale
Emotional disorders and possible comorbidities: assessed by the Youth Self Report (YSR) self-questionnaire, 15 minutes
Measured: T0 (13.5 years old +/-6 months); T1 (15.5 years old+/-6 months); T2 ( 17.5 years old +/-6 months)
Suicidal risk
Columbia-Suicide Severity Rating Scale (C-SSRS score >4), in case of suicidal ideation identified through the MINI
Measured: T0 (13.5 years old +/-6 months); T1 (15.5 years old+/-6 months); T2 ( 17.5 years old +/-6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start25 Jun 2024
- Primary completion24 Jun 2029 (estimated)
- Study completion24 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender DysphoriaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, controlled, randomized, open trial with blinded evaluation of the primary endpoint (Prospective Open Blinding Endpoint PROBE study). Randomization will be stratified by sex assigned at birth and the investigating center. The primary analysis will be intention-to-treat and multiple imputation methods will be used to handle missing data. After verification of the inclusion criteria by the child psychiatrist (selection visit), then the pediatric endocrinologist (inclusion visit), the adolescent will be included in the study and will benefit from an initial evaluation (T0) by a psychologist trained for the primary criterion (CGAS) and secondary psycho-affective criteria. The patients will then be sent again to the pediatric endocrinologist who will randomize the patient (via an IT platform) and give them the treatment corresponding to their assigned group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David COHEN, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351501
- Sponsor's protocol ID
- P170923J
- Other IDs
- 2019-000300-16, 2019
- Acronym
- TRANSADO
- Status last verified
- Aug 2026
- First submitted
- 2 Apr 2024
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Hormonal Treatment in Adolescents Suffering From Gender Dysphoria
- ClinicalTrials.gov ID
- NCT06351501
- Acronym / sponsor ID
- TRANSADO / P170923J
- Conditions
- Gender Dysphoria
- Keywords
- Gender Dysphoria, adolescents, hormonal treatment, mental health
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 24 Jun 2029 (estimated)
- Study completion
- 24 Jun 2031 (estimated)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Multicenter, controlled, randomized, open trial with blinded evaluation of the primary endpoint (Prospective Open Blinding Endpoint PROBE study). Randomization will be stratified by sex assigned at birth and the investigating center. The primary analysis will be intention-to-treat and multiple imputation methods will be used to handle missing data. After verification of the inclusion criteria by the child psychiatrist (selection visit), then the pediatric endocrinologist (inclusion visit), the adolescent will be included in the study and will benefit from an initial evaluation (T0) by a psychologist trained for the primary criterion (CGAS) and secondary psycho-affective criteria.The patients will then be sent again to the pediatric endocrinologist who will randomize the patient (via an IT platform) and give them the treatment corresponding to their assigned group. Adolescents in both groups will be reassessed at 15.5 years +/- 6 months (T1). At the end of this evaluation, patients in the control group will begin their hormonal treatment. Adolescents will undergo a final evaluation at 17.5 years +/- 6 months (T2), at which time the same criteria as at T0 and T1 will be collected.
Main objective: To evaluate, in gender dysphoric adolescents, having completed their social transition, having or not undergone prior pubertal suppression, the effectiveness of hormonal treatment with estrogens or testosterone initiated at 13.5 years +/- 6 months of age on the overall functioning of the teenager at 15.5 years +/- 6 months old.
Primary endpoint: Children's Global Assesment Scale (CGAS) score at age 15.5 +/- 6 months
Secondary objectives : Evaluate, in gender dysphoric adolescents who have completed their social transition, whether or not they have benefited from prior pubertal suppression:
- the effectiveness of hormonal treatment started at 13.5 years old +/- 6 months vs. 15.5 years old +/- 6 months on the overall functioning of the adolescent at 17.5 years old+/- 6 months,
- the safety (side effects) of hormonal treatment started at age 13.5 +/- 6 months,
- and the relevance of hormonal treatment started at 13.5 years old +/- 6 months on other parameters assessed at 15.5 +/- 6 months and 17.5 +/- 6 months years old (gender identity, depression, anxiety, emotional, behavioral disorders and other comorbidities, objective and subjective quality of life, body image, height, waist/hip ratio, bone mineral density, BMI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter, controlled, randomized, open trial with blinded evaluation of the primary endpoint (Prospective Open Blinding Endpoint PROBE study). Randomization will be stratified by sex assigned at birth and the investigating center. The primary analysis will be intention-to-treat and multiple imputation methods will be used to handle missing data. After verification of the inclusion criteria by the child psychiatrist (selection visit), then the pediatric endocrinologist (inclusion visit), the adolescent will be included in the study and will benefit from an initial evaluation (T0) by a psychologist trained for the primary criterion (CGAS) and secondary psycho-affective criteria. The patients will then be sent again to the pediatric endocrinologist who will randomize the patient (via an IT platform) and give them the treatment corresponding to their assigned group.
| Arm | Type | Receives |
|---|---|---|
| early hormonal treatment | Experimental | Drug: hormonal treatment with cross sex hormones (testosterone or oestrogenes) started at 14 years old +/- 6 monthsearly hormonal treatment initiated at 13.5 years +/- 6 months, in addition to usual care |
| usual treatment | Active comparator | Drug: Cross sex hormones ( œstrogenes or testosterone) started at 15.5 years old +/- 6 monthsUsual care between 13.5 and 15.5 years +/- 6 months : child psychiatric consultations, endocrinological consultations and consultations with a psychologist, family interviews, network work with local health partners and national education. Then hormonal treatment initiated at 15.5 years +/- 6 months, in addition to usual care. |
Who may qualify
- Ages
- 156 to 168 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hormonal treatment with cross sex hormones (testosterone or oestrogenes) started at 14 years old +/- 6 months4 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) | Drug | early hormonal treatment |
| Cross sex hormones ( œstrogenes or testosterone) started at 15.5 years old +/- 6 months2 years of hormonal treatment from 15.5 old +/- 6 months to 17.5 years old +/- 6 months | Drug | usual treatment |
Primary outcome
Global functionning using the Children's Global Assessment Scale (CGAS)
Time frame: 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.
17 secondary outcomes
Drug use (DEP-ADO)
Time frame: T0 (13.5 years old +/-6 months); T1 (15.5 years old+/-6 months); T2 ( 17.5 years old +/-6 months)
WISC-V (weschler Test)
Time frame: T0 (13.5 years old +/-6 months); T2 ( 17.5 years old +/-6 months)
UGDS (Utrecht Gender Dysphoria Scale ) and GIDYQ-AA (Gender Identity/ Gender Dysphoria Questionnaire for Adolescents and Adults scale )
Time frame: selection visit ; T1 (15.5 years old +/-6 months) ; T2 (17.5 years old +/-6 months)
Beck Depression Inventory (BDI)
Time frame: T0 (13.5 years old +/-6 mois); T1 (15.5 years old+/-6 monhs); T2 ( 17.5 years old +/-6 months)
Body Image Scale (BIS)
Time frame: T0 (13.5 years old +/-6 months); T1 (15.5 years old+/-6 months); T2 ( 17.5 years old +/-6 months)
State and Anxiety Inventory for Children (STAI-C)
Time frame: T0 (13.5 years old +/-6 mois); T1 (15.5 years old+/-6 monhs); T2 ( 17.5 years old +/-6 months)
World Health Organization Quality Of Life - BREF (WHOQOL-BREF)
Time frame: T0 (13.5 years old +/-6 months); T1 (15.5 years old+/-6 months); T2 ( 17.5 years old +/-6 months)
Satisfaction With Life Scale (SWLS)
Time frame: T0 (13.5 years old +/-6 months); T1 (15.5 years old+/-6 months); T2 ( 17.5 years old +/-6 months)
Height, bone mineral density, BMI, waist to hip ratio
Time frame: inclusion visit (13.5 years old +/-6 months); T1 (15.5 years old+/-6 months); T2 ( 17.5 years old +/-6 months)
Mini International Neuropsychiatric Interview (MINI)
Time frame: selection visit ; T1 (15.5 years old+/-6 months); T2 ( 17.5 years old +/-6 months)
The emotional and sexual relationship
Time frame: T0 (13.5 years old +/-6 months); T1 (15.5 years old+/-6 months); T2 ( 17.5 years old +/-6 months)
School drop-out / family breakdown
Time frame: T0 (13.5 years old +/-6 months); T1 (15.5 years old+/-6 months); T2 ( 17.5 years old +/-6 months)
Global Assesment Scale (GAS)
Time frame: T2 : 17.5 years old +/-6 months
Potential side-effects
Time frame: T0 (13.5 years old +/-6 months); T1 (15.5 years old+/-6 months); T2 ( 17.5 years old +/-6 months)
Child Behaviour Checklist (CBCL) scale
Time frame: T0 (13.5 years old +/-6 months); T1 (15.5 years old+/-6 months); T2 ( 17.5 years old +/-6 months)
Youth Self Report (YSR) scale
Time frame: T0 (13.5 years old +/-6 months); T1 (15.5 years old+/-6 months); T2 ( 17.5 years old +/-6 months)
Suicidal risk
Time frame: T0 (13.5 years old +/-6 months); T1 (15.5 years old+/-6 months); T2 ( 17.5 years old +/-6 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David COHEN, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing hormonal treatment with cross sex hormones (testosterone or oestrogenes) started at 14 years old +/- 6 months and Cross sex hormones ( œstrogenes or testosterone) started at 15.5 years old +/- 6 months in people with Gender Dysphoria, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David COHEN, MD,PhD (01 42 16 23 51 ext. +33, david.cohen@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global functionning using the Children's Global Assessment Scale (CGAS) (time frame: 15.5 years old +/- 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.