Early Mental Response - The EMRE Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-99
SponsorKarolinska University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Testosterone treatment
DrugCross-sex hormone therapy consisting of intramuscular injection of testosterone undecanoate 250mg/ml. 4ml (total dosage of 1000mg) administered by trained nurse in the gluteal region at visit 1.
Placebo treatment
Other interventionSaline solution. Intramuscular injection of physiological saline solution. 4ml administered by trained nurse in the gluteal region at visit 1.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Active comparator armActive comparator 1 intervention
Group B: Placebo comparator armPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes in baseline gender incongruence at 2 and 6 weeks respectively
Score according to Transgender Congruence Scale. The total score ranges from a mean value of 12 items scored from 1 to 5. The mean value ranges from 1 to 5 points in total. A low score indicates a high level of gender dysphoria and a high score indicates a low level of gender dysphoria.
Time frame
Performed at visit 2 (pre treatment), 2 weeks into treatment (performed at distance) and after 6 weeks of treatment (visit 3, study ends).Secondary outcomes
1
Changes in baseline slef-esteem at 2 and 6 weeks respectively.
Scores according to Rosenberg self-esteem scale. The scale contains 10 items scored from 0 to 3 points. Total score ranges from 0-30 points. High scores indicate a high self-esteem and low scores indicate a low self-esteem.
Time frame
Performed at visit 2 (pre treatment), 2 weeks into treatment (performed at distance) and after 6 weeks of treatment (visit 3, study ends).2
Changes in baseline quality of life at 2 and 6 weeks respectively.
Scores according to Brunnsviken Brief Quality of Life Inventory. The scale contains 12 items scored from 0 to 4. The total score ranges from 0 to 96 points. A low score indicates a low quality of life and a high score indicates a high quality of life.
Time frame
Performed at visit 2 (pre treatment), 2 weeks into treatment (performed at distance) and after 6 weeks of treatment (visit 3, study ends).3
Changes in baseline sexual desire at 2 and 6 weeks respectively.
Scores according to Sexual Desire Inventory. The scale contains 13 items in total. Items are scored from 0 to 5. Total score ranges from 0 to 101 points measuring total sexual desire. Items 1 to 9 contains a subscale measuring dyadic sexual desire. Items 10 to 13 contains a subscale measuring solitary sexual desire. A low score indicates a low sexual desire and a high score indicates a high sexual desire on both the main scale and subscales.
Time frame
Performed at visit 2 (pre treatment), 2 weeks into treatment (performed at distance) and after 6 weeks of treatment (visit 3, study ends).4
Changes in baseline aggression at 2 and 6 weeks respectively.
Scores according to Buss-Perry Aggression Questionnaire. The scale contains 29 items in total scored from 1 to 5. Total score ranges from 29 to 145. The scale includes 4 subscales. Physical Aggression (items 1-9), verbal Aggression (items 10-14), anger (items 15-21), and hostility (items 22-29). A high score indicates high aggression and a low score indicates low aggression on both the main scale and subscales.
Time frame
Performed at visit 2 (pre treatment), 2 weeks into treatment (performed at distance) and after 6 weeks of treatment (visit 3, study ends).Sponsors and contacts
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Source ClinicalTrials.gov