Early Mental Response to Hormonal Treatment in Transgender Men - The EMRE Study

What this Trial Is About

This research aims to study whether transgender men experience an improvement in their feeling of gender incongruence within six weeks of hormonal treatment compared to a placebo. It also examines changes in self-esteem, quality of life, sexual desire, aggression, depression/anxiety, impulsiveness, and emotional reactivity during this period. Gender dysphoria is a condition where there is a mismatch between one's body and gender identity, often treated by hormone therapy and surgery. This study seeks to understand how hormone treatment affects the brain early on, contributing to knowledge about the condition and its treatment. Participants receive either testosterone undecanoate injections or a placebo (saline solution) given intramuscularly by a nurse at the start of the study. The treatment is administered once at the first visit, with the study lasting six weeks. After this period, all participants are offered standard testosterone treatment as part of clinical care. The study is randomized and double-blind, meaning neither participants nor researchers know who receives testosterone or placebo during the study. During the study, participants complete assessments measuring gender congruence, self-esteem, quality of life, sexual desire, aggression, depression/anxiety, impulsiveness, and emotional reactivity at the start, after two weeks (done remotely), and at six weeks (end of study). Blood samples are collected before treatment and after six weeks to monitor hormone levels and safety. The total blood volume collected is up to 40 ml per participant. The study evaluates changes in these measures to understand the early effects of hormone therapy in transgender men.

Early Mental Response - The EMRE Study