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Study identifier: NCT05649605 Synced from ClinicalTrials.gov · July 28, 2026
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Early Mental Response - The EMRE Study

Condition: Gender Dysphoria · Gender Identity · Gender Issues  ·  Sponsor: Karolinska University Hospital

PhaseNA
Planned participants70
Who can joinFemale, 18 Years to 99 Years
Healthy volunteersNo

About this study

Primary question: Does transgender men's experience of gender incongruence improve within 6 weeks of hormonal treatment compared to placebo? Long before any bodily changes occur. Secondary question: Does transgender men´s experience of self-esteem, quality of life, sexual desire, aggression, depression/anxiety, impulsiveness, and emotional reactivity improve during 6 weeks of cross-sex hormone therapy compared to placebo? Gender dysphoria is a condition characterized by a perceived incongruence between the body and identity. For several decades this condition has been treated with cross-sex hormone therapy and surgery, among others, in order to change the body to be more congruent with the perceived gender identity. Patient satisfaction with this treatment is very high where an overwhelming majority of patients live the rest of their lives according to their perceived gender. A clinical observation, however, is that most patients experience that the congruence between the perceived gender and the assigned one improves very quickly on hormonal treatment. Long before any changes to the body have taken place. This may be partly due to relief from having finally started treatment (i.e. a psychological/social explanation) but an alternative (and much more likely) explanation is that the hormonal treatment directly affects the brain. Since the cause of gender dysphoria is unknown today, this study is therefore a step in trying to clarify the mechanism. In addition, it is of value …

This description comes directly from the study's public registry record.

Talk to the study team

Mats Holmberg, MD. PhD.  ·  +46705266365  ·  mats.holmberg.1@ki.se

Anders Hagelin, MD.  ·  +46736265973  ·  anders.hagelin@ki.se

Always discuss trial participation with your own doctor first.

Locations (1)

Karolinska Universitetssjukhuset, ANOVAStockholm, SwedenRecruiting

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Source record: clinicaltrials.gov/study/NCT05649605