Early Mental Response - The EMRE Study (EMRE)
Gender Dysphoria, Gender Identity, Gender Issues
About this trial
This is an interventional basic science trial for Gender Dysphoria
Eligibility Criteria
Inclusion criteria: Well-informed written consent to participate in the study. Transgender man given the ICD-10 diagnosis of transsexualism. A desire for complete gender-confirming hormonal treatment. Approved for Nebido treatment by a clinically responsible Endocrinologist. Exclusion criteria: 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.). A disability that prevents the patient from fully participating in the study. Treatment with steroid hormones (androgens, estrogens, progestogens, or continuous treatment with oral corticosteroids within the last three months). Previous use of hormone preparations without a doctor's prescription. Laboratory samples significantly outside the normal reference range. Anamnestic or investigational suspicion of breast cancer or existing or previous liver tumors. Levels of P-ASAT, P-ALAT, or P-GT at the screening time that are> 2 times the reference range. Hypersensitivity to the active substance or to any of the excipients. Ongoing pregnancy or wishes for a pregnancy in the near future.
Sites / Locations
- Karolinska Universitetssjukhuset, ANOVARecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Active comparator arm
Placebo comparator arm
Active treatment
Placebo treatment