Early Mental Response - The EMRE Study (NCT05649605) | Clinical Trial Compass
RecruitingNot Applicable
Early Mental Response - The EMRE Study
Sweden70 participantsStarted 2023-03-07
Plain-language 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.
Who can participate
Age range
18 Years – 99 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in baseline gender incongruence at 2 and 6 weeks respectively
Timeframe: Performed at visit 2 (pre treatment), 2 weeks into treatment (performed at distance) and after 6 weeks of treatment (visit 3, study ends).
. 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.