What is testosterone studying for gender dysphoria?

This clinical trial is studying how testosterone treatment affects early mental responses in transgender men with gender dysphoria. Researchers want to find out if testosterone improves feelings of gender incongruence and related psychological factors compared to a placebo. The study is sponsored by Karolinska University Hospital and aims to better understand hormone effects on the brain in this population.

Who may be eligible for this gender dysphoria clinical trial?

Adults aged 18 to 99 who are transgender men diagnosed with transsexualism according to ICD-10 and approved for testosterone treatment by an endocrinologist may be eligible. The trial requires participants to have no current pregnancy and no hormone-related medical conditions. Please review eligibility criteria for more details.

Is there any cost to participate in this gender dysphoria clinical trial?

Study-related care, including the hormone injection or placebo and all trial visits, is provided at no cost. Personal travel and other expenses may vary and are not guaranteed to be covered. Participants can expect to receive study treatments and monitoring without paying for these services.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 99Years

FEMALE

ID05649605

Studying Early Brain Effects of Testosterone Hormone Therapy in Adult Transgender Men Compared to Placebo

Led by Karolinska University Hospital · Updated on 2023-03-08

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

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, depressionanxiety, impulsiveness, and emotional reactivity during this period. Gender dysphoria is a condition where there is a mismatch between ones 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, depressionanxiety, 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.

CONDITIONS

Brief Title

Early Mental Response - The EMRE Study

Who Can Participate

Age: 18Years - 99Years

FEMALE

Eligibility Criteria

You may qualify if you...

Provide well-informed written consent to participate in the study.
Be a transgender man diagnosed with transsexualism according to ICD-10.
Desire complete gender-confirming hormonal treatment.
Be approved for Nebido (testosterone) treatment by a clinically responsible endocrinologist.

You will not qualify if you...

Have a hormonal condition affecting the gonadal axis such as Congenital Adrenal Hyperplasia, Polycystic Ovary Syndrome, or androgen insensitivity syndromes.
Have a disability that prevents full participation in the study.
Have used steroid hormones or oral corticosteroids continuously in the last three months.
Have previously used hormone preparations without a doctor's prescription.
Have laboratory test results significantly outside the normal reference ranges.
Have current or past breast cancer or liver tumors.
Have liver enzyme levels (P-ASAT, P-ALAT, or P-GT) more than twice the reference range.
Have hypersensitivity to the active substance or any excipients in the treatment.
Are currently pregnant or wish to become pregnant in the near future.

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Treatment

Duration - 6 weeks

Participants receive an intramuscular injection of testosterone or placebo and are monitored for six weeks to study early mental effects of hormone treatment.

1 baseline visit (in-person) and assessments performed remotely at 2 weeks; 1 final visit (in-person) at 6 weeks