Gender Dysphoria Clinical Trial
— EMREOfficial title:
Early Mental Response to Hormonal Treatment in Transgender Men - The EMRE Study
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.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | December 30, 2026 |
Est. primary completion date | December 30, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 99 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Sweden | Karolinska Universitetssjukhuset, ANOVA | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska University Hospital |
Sweden,
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* Note: There are 30 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Performed at visit 2 (pre treatment), 2 weeks into treatment (performed at distance) and after 6 weeks of treatment (visit 3, study ends). | |
Secondary | 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. | Performed at visit 2 (pre treatment), 2 weeks into treatment (performed at distance) and after 6 weeks of treatment (visit 3, study ends). | |
Secondary | 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. | Performed at visit 2 (pre treatment), 2 weeks into treatment (performed at distance) and after 6 weeks of treatment (visit 3, study ends). | |
Secondary | 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. | Performed at visit 2 (pre treatment), 2 weeks into treatment (performed at distance) and after 6 weeks of treatment (visit 3, study ends). | |
Secondary | 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. | Performed at visit 2 (pre treatment), 2 weeks into treatment (performed at distance) and after 6 weeks of treatment (visit 3, study ends). | |
Secondary | Changes in baseline depressive symptoms and anxiety at 2 and 6 weeks respectively. | Scores according to Montgomery Asberg Depression Rating Scale.The scale contains 9 items scored from 0 to 6. Total score ranges from 0 to 54. 0 to12 indicates no or mild depression. 13 to 19 points indicate mild depression. 20 to 34 indicate mild depression. 35 to 54 indicate severe depression. | Performed at visit 2 (pre treatment), 2 weeks into treatment (performed at distance) and after 6 weeks of treatment (visit 3, study ends). | |
Secondary | Changes in baseline impulsiveness at 2 and 6 weeks respectively. | Scores according to Barratt Impulsiveness Scale. The scale contains 30 items scored from 1 to 4. Total score ranges from 30 to 120. The scale contains 3 subscales. Attentional scale with a total of 8 items (divided in two - attention and cognitive instability, 5 and 3 items respectively). Motor scale with a total of 11 items (divided in two - attention and cognitive instability, 7 and 4 items respectively). Non-planning scale (divided in two - self-control and cognitive complexity, 6 and 5 items respectively). A high score indicates a high impulsiveness and a low score indicates a low impulsiveness on all scales. | Performed at visit 2 (pre treatment), 2 weeks into treatment (performed at distance) and after 6 weeks of treatment (visit 3, study ends). | |
Secondary | Changes in baseline emotional reactivity at 2 and 6 weeks respectively. | Scores according to Perth Emotional Reactivity Scale-Short Form. The scale contains 18 items scored from 1 to 5. Total score ranges from 18 to 90. The scale contains 8 sub scales. Negative-activation-scale, sum total score from items 2, 8, 14. Negative-intensity-scale, sum total score from items 6, 12, 18. Negative-duration-scale, sum items 4, 10, 16. Positive-activation-scale, sum total score from items 1, 7, 13. Positive-intensity-scale, sum total score from items 5, 11, 17. Positive-duration-scale, sum total score from items 3, 9, 15. General negative reactivity-scale, sum total score from all even numbered items. General positive reactivity-scale, sum total score from all odd numbered items. A high score indicates a high emotional reactivity and a low score indicates a low emotional reactivity on all scales. | Performed at visit 2 (pre treatment), 2 weeks into treatment (performed at distance) and after 6 weeks of treatment (visit 3, study ends). |
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