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Tests treatment safety and results for Gender Dysphoria
Official title Evaluation of the Effectiveness of Hormonal Treatment in Adolescents Suffering from Gender Dysphoria
ClinicalTrials.gov ID: NCT06351501
What this study is testing
What is hormonal treatment with cross sex hormones (testosterone or oestrogenes) started at 14 years old +/- 6 months?
hormonal treatment with cross sex hormones (testosterone or oestrogenes) started at 14 years old +/- 6 months is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for gender dysphoria.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 162 to 174
You may be able to join if
- Adolescents aged 14+/- 6 months,
- Having initiated puberty: tanner score ≥2 for FtM; tanner score ≥2 (clinic and/or testosterone \>0.3 ng/mL) for MtF
- Presenting the criteria for gender dysphoria according to the DSM5 assessed by at least two child psychiatric interviews at least six months apart...
- Whose indication for hormonal transition has been validated in a multidisciplinary consultation meeting after at least one consultation with the...
You likely can't join if
- Contraindication to hormonal treatment (see paragraph 1.5)
- Hormonal treatment needs to be adjusted (FtM patients treated with anti-coagulants or with thrombophilia).
- Patients with risk of aggravation of certain diseases under oestrogen treatment (MtF patients with uncontrolled diabetes with HBA1C \> 8%, patients...
- 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...
- Uncontrolled high blood pressure.
See the full eligibility criteria
- Adolescents aged 14+/- 6 months,
- Having initiated puberty: tanner score ≥2 for FtM; tanner score ≥2 (clinic and/or testosterone \>0.3 ng/mL) for MtF
- 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...
- 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...
- Contraindication to hormonal treatment (see paragraph 1.5)
- Hormonal treatment needs to be adjusted (FtM patients treated with anti-coagulants or with thrombophilia).
- Patients with risk of aggravation of certain diseases under oestrogen treatment (MtF patients with uncontrolled diabetes with HBA1C \> 8%, patients with cholelithiasis, biliary lithiasis, systemic lupus erythematosus...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Paris, Paris, France
- Le Kremlin-Bicêtre, Île-de-France Region, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 162 months to 174 months. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, Paris, France; Le Kremlin-Bicêtre, Île-de-France Region, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.