Early Mental Response - The EMRE Study

• Status: Not yet recruiting
• Trial end date: 2026-12-30
• Target enrollment: 0
• Participant gender: Female

Summary

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 to be able to demonstrate the benefits of hormonal treatment in these patients. Finally, there is a basic research motive for this study. The effect of sex hormones on the brain is very well known from a clinical perspective but all the more unknown from a research perspective. This study will contribute knowledge in this area.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karolinska University Hospital
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion criteria:

1. Well-informed written consent to participate in the study.

2. Transgender man given the ICD-10 diagnosis of transsexualism.

3. A desire for complete gender-confirming hormonal treatment.

4. Approved for Nebido treatment by a clinically responsible Endocrinologist.

Exclusion criteria:

1. A concomitant hormonal condition affecting the gonadal axis (e.g. Congenital Adrenal Hyperplasia, Poly Cystic Ovary Syndrome, Complete Androgen Insensitivity Syndrome, Partial Androgen Insensitivity Syndrome, untreated thyroid disease, untreated hypercortisolism, etc.).

2. A disability that prevents the patient from fully participating in the study.

3. Treatment with steroid hormones (androgens, estrogens, progestogens, or continuous treatment with oral corticosteroids within the last three months).

4. Previous use of hormone preparations without a doctor's prescription.

5. Laboratory samples significantly outside the normal reference range.

6. Anamnestic or investigational suspicion of breast cancer or existing or previous liver tumors.

7. Levels of P-ASAT, P-ALAT, or P-GT at the screening time that are> 2 times the reference range.

8. Hypersensitivity to the active substance or to any of the excipients.

9. Ongoing pregnancy or wishes for a pregnancy in the near future.