Study to Compare Early Versus Standard Age Hormonal Treatment in Adolescents with Gender Dysphoria to Improve Functioning and Quality of Life

What this Trial Is About

Gender dysphoria GD causes significant distress lasting more than six months due to a mismatch between an individuals gender identity and birth sex. This trial evaluates the effectiveness of starting hormonal treatment earlier, around 13.5 years of age, compared to the usual start at 15.5 years, for transgender adolescents who have completed their social transition and begun puberty. It aims to reduce anxiety, depression, and other co-morbidities and improve quality of life and overall functioning. This is a Phase 3 multicenter, randomized, open trial with blinded evaluation of the primary outcome. Participants will be randomly assigned to one of two groups early hormonal treatment starting at 13.5 years plus usual care, or usual care with hormonal treatment starting later at 15.5 years. The hormonal treatments include cross-sex hormones such as testosterone or estrogens delivered via gels or tablets. The study includes initial assessments at inclusion, follow-ups at 15.5 years and 17.5 years to evaluate outcomes, with treatment durations varying by group. The control group begins hormonal treatment after the 15.5-year assessment. Throughout the study, participants undergo evaluations by psychologists and pediatric endocrinologists, including assessments of overall functioning, gender identity, depression, anxiety, quality of life, body image, physical health measures, and potential side effects. Standardized scales and interviews, such as the Childrens Global Assessment Scale CGAS and psychiatric interviews, are used at specified time points. The trial spans approximately four years, with final evaluations at 17.5 years of age to determine the impact of early versus later hormonal treatment.

Evaluation of the Effectiveness of Hormonal Treatment in Adolescents Suffering From Gender Dysphoria