Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06351501
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-04-02
Brief Title:
Evaluation of the Effectiveness of Hormonal Treatment in Adolescents Suffering From Gender Dysphoria
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Evaluation of the Effectiveness of Hormonal Treatment in Adolescents Suffering From Gender Dysphoria
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRANSADO
Brief Summary:
Gender dysphoria GD is a significant suffering lasting more than 6 months in a subject regarding the gap felt between gender identity of someone and birth sex From the start of puberty most of these adolescents who identify as transgender will persist in this sense and will engage in hormonal-surgical reassignment at some stage For these adolescents International recommendations for good practice recommend early treatment at the beginning of pubertal development Tanner 2 to block pubertal progression with the possibility of hormonal transition by administration of sex hormones of the desired sex at the age of 16 However in order to reduce the psychosocial consequences of GD more and more reference teams are practicing this hormonal transition from the age of 14 without any randomized study showing its benefit compared to a transition at the age of 16 years old Indeed in the absence of treatment comorbidities among adolescents suffering from gender dysphoria is very high with anxiety and depression suicidal risk and school dropout
Our hypothesis is that when hormonal transition is started at an age closer to what physiological puberty would be it will reduce comorbidities and improve quality of life of these adolescents This is the first therapeutic randomized study in France on this transgender adolescent population a field where international recommendations based on Evidence Based Medicine principles are scared We hope that results of this study will guide transgender youth health care allowing them if the study is positive to access hormonal treatments earlier and improve their overall functioning their anxious and depressive symptoms their quality of life
Our hypothesis is that when hormonal transition is started at an age closer to what physiological puberty would be it will reduce comorbidities and improve quality of life of these adolescents This is the first therapeutic randomized study in France on this transgender adolescent population a field where international recommendations based on Evidence Based Medicine principles are scared We hope that results of this study will guide transgender youth health care allowing them if the study is positive to access hormonal treatments earlier and improve their overall functioning their anxious and depressive symptoms their quality of life
Detailed Description:
This study is a multicentered controlled randomized open trial with blinded assessment of the primary outcome measure Prospective Open Blinding Endpoint PROBE study Randomization will be stratified by sex assigned at birth and the investigating center The main analysis will be intention-to-treat and multiple imputation methods will be used to handle missing data Once inclusion criteria are checked by the child psychiatrist selection visit and the pediatric endocrinologist inclusion visit the adolescent will be included in the study with an initial evaluation T0 by a trained psychologist primary measure CGAS and secondary psycho-affectif criteria Then the subject will randomized by the pediatric endocrinologist via an IT platform and if included in the experimental arm will be given the cross sex hormonal treatment correspondingMain objective To evaluate in adolescents with gender dysphoria GD having or not benefited from prior pubertal suppression the effectiveness of cross sex hormonal treatment with estrogens or testosterone initiated at 14 years of age on the overall functioning of the teenager at 16 years old Primary outcome measure Childrens Global Assessment Scale CGAS score at age 16 Secondary measures Evaluate the effectiveness of cross sex hormonal treatment started at 14 years old vs 16 years old on the overall functioning of the adolescent at 18 years old - the safety side effects of hormonal treatment started at the age of 14 - and the relevance of hormonal treatment started at 14 years old on other measures assessed at 16 and 18 years old gender identity depression anxiety emotional behavioral disorders and other comorbidities objective and subjective quality of life body image height waisthip ratio bone mineral density BMI Adolescents in both groups will be re-evaluated at 16 years - 6 months T1 At the end of this evaluation patients in the control group will begin their hormonal treatment Adolescents will benefit from a final evaluation at 18 years - 6 months T2 the same criteria as at T0 and T1 will be collected
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-000300-16 | EUDRACT_NUMBER | None | None |