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โ† Trials
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Early Mental Response - The EMRE Study

RecruitingNAAges 18 Years - 99 YearsFemaleKarolinska University Hospital
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In plain words

What the trial is, and whether it could suit you

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 menยดs 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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Testosterone treatment
  • Placebo treatment
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Where

1 site
Karolinska Universitetssjukhuset, ANOVA
Stockholm, Sweden
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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