Skip to content

TRANSADO - Evaluation of the effectiveness of hormonal treatment in adolescents suffering from gender dysphoria

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513250-30-00
Acronym
P170923J
Enrollment
60
Registered
2024-09-16
Start date
2024-06-25
Completion date
Unknown
Last updated
2025-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gender dysphoria

Brief summary

The primary outcome measure is the adolescent's global functioning as assessed by the Children's Global Assessment Scale (CGAS) at age 16 years old +/- 6 months.

Detailed description

- Global Assesment Scale (GAS) at T2., - Weschler scale (WISC V) at T0 et T2,, - The Gender Identity/ Gender Dysphoria Questionnaire for Adolescents and Adults scale (GIDYQ-AA) and the Utrecht Gender Dysphoria Scale (UGDS) at selection visit, T1 et T2,, - Beck Depression Inventory (BDI) scale at T0, T1 et T2,, - Body Image Scale (BIS) scale at T0, T1 et T2,, - State-Trait Anxiety Inventory for Children (STAIC) scale at T0, T1 et T2,, - Child Behaviour Checklist (CBCL) scale at T0, T1 et T2,, - MINI International Neuropsychiatric Interview (MINI) at selection visit, T1 et T2, - Youth Self Report (YSR) scale at T0, T1 et T2,, - World Health Organization Quality Of Life - BREF (WHOQOL-BREF) scale at T0, T1 et T2,, - Satisfaction With Life Scale (SWLS) at T0, T1 et T2., - Height, bone mineral density, BMI, waist to hip ratio at inclusion visit, T1 et T2., - Potential side-effects at T0, T1 et T2., - The emotional and sexual relationship: assessed by specific questions at T0, T1 et T2, - Drug use: assessed by specific questions via the DEP-ADO questionnaire (screening grid for problem substance use among adolescents) at T0, T1 and T2, - School drop-out / family breakdown: assessed by specific questions at T0, T1 et T2, Psycho-affective criteria will be assessed by a psychologist trained in the relevant assessment scales, while somatic criteria will be collected by the pediatric endocrinologist.

Interventions

DRUG2 mg/g
DRUGgel
DRUGPROVAMES 1 mg
DRUGcomprimé pelliculé
DRUGESTREVA 0
DRUG1 %

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
The primary outcome measure is the adolescent's global functioning as assessed by the Children's Global Assessment Scale (CGAS) at age 16 years old +/- 6 months.

Secondary

MeasureTime frame
- Global Assesment Scale (GAS) at T2., - Weschler scale (WISC V) at T0 et T2,, - The Gender Identity/ Gender Dysphoria Questionnaire for Adolescents and Adults scale (GIDYQ-AA) and the Utrecht Gender Dysphoria Scale (UGDS) at selection visit, T1 et T2,, - Beck Depression Inventory (BDI) scale at T0, T1 et T2,, - Body Image Scale (BIS) scale at T0, T1 et T2,, - State-Trait Anxiety Inventory for Children (STAIC) scale at T0, T1 et T2,, - Child Behaviour Checklist (CBCL) scale at T0, T1 et T2,, - MINI International Neuropsychiatric Interview (MINI) at selection visit, T1 et T2, - Youth Self Report (YSR) scale at T0, T1 et T2,, - World Health Organization Quality Of Life - BREF (WHOQOL-BREF) scale at T0, T1 et T2,, - Satisfaction With Life Scale (SWLS) at T0, T1 et T2., - Height, bone mineral density, BMI, waist to hip ratio at inclusion visit, T1 et T2., - Potential side-effects at T0, T1 et T2., - The emotional and sexual relationship: assessed by specific questions at T0, T1 et T2, - Dr

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026