Early Mental Response to Hormonal Treatment in Transgender Men - The EMRE Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Changes in baseline gender incongruence at 2 and 6 weeks respectively
研究概览
简要总结
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.
详细描述
1.1 Gender dysphoria (GD) is currently a psychiatric diagnosis in Sweden. To meet the criteria according to the International Classification of Diseases (ICD-10), the patient must demonstrate a strong and persistent cross-gender identification coupled with persistent discomfort with his or her sex. ICD-10 uses the term "transsexualism" rather than "gender dysphoria". For the purpose of this study, we limit ourselves to adult transgender men by defining transsexualism in accordance with the diagnostic criteria for ICD-10.
GD is associated with significant suffering, reduced quality of life, and high self-reported disabilities. Comorbidity with other psychiatric diagnoses is high and the condition is linked to minority stress and discrimination.
1.2 Gender-confirming hormone therapy Cross-sex hormone therapy (CHT) is in most cases an important part of gender-confirming care of binary trans people. In trans men (assigned women at birth), CHT usually consists of testosterone alone. The method of administration is either topical gel or intramuscular injection. In this study, subjects are consequently treated with testosterone through intramuscular injection.
1.3 Effects of estradiol on the brain Estradiol is the predominant estrogen used as part of CHT in trans women. In trans men, the total levels of estradiol are lowered to levels equivalent to those of cis-men through negative feedback from testosterone administration. Estradiol is a steroid hormone that diffuses easily across the cell membrane and the blood-brain barrier (BBB), thus affecting the brain.
Sudden falls in estradiol concentrations and persistent estradiol deficiency are linked to mood swings. A suggested cause is estradiol's effect on dopaminergic, cholinergic, Gamma-aminobutyric acid (GABA) ergic, glutamatergic and serotonergic neurotransmission. Estradiol increases serotonin levels and other monoamines in the synapse by affecting monoamine oxidase and intraneuronal serotonin transport activity. It has also been suggested to increase binding sites in areas of the brain relevant to mood and cognition, and to increase binding to the serotonin 2A receptor - the most common serotonin receptor in the brain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All participating research staff will be blinded to the treatment the patient is receiving. The drug and placebo will be labelled by Tamro AB, which will ensure that Nebido and placebo cannot be separated.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Active comparator arm
Active treatment
干预措施: Testosterone treatment (Drug)
Placebo comparator arm
Placebo treatment
干预措施: Placebo treatment (Other)
结局指标
主要结局
Changes in baseline gender incongruence at 2 and 6 weeks respectively
时间窗: Performed at visit 2 (pre treatment), 2 weeks into treatment (performed at distance) and after 6 weeks of treatment (visit 3, study ends).
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.
次要结局
- Changes in baseline quality of life at 2 and 6 weeks respectively.(Performed at visit 2 (pre treatment), 2 weeks into treatment (performed at distance) and after 6 weeks of treatment (visit 3, study ends).)
- Changes in baseline slef-esteem at 2 and 6 weeks respectively.(Performed at visit 2 (pre treatment), 2 weeks into treatment (performed at distance) and after 6 weeks of treatment (visit 3, study ends).)
- Changes in baseline sexual desire at 2 and 6 weeks respectively.(Performed at visit 2 (pre treatment), 2 weeks into treatment (performed at distance) and after 6 weeks of treatment (visit 3, study ends).)
- Changes in baseline impulsiveness at 2 and 6 weeks respectively.(Performed at visit 2 (pre treatment), 2 weeks into treatment (performed at distance) and after 6 weeks of treatment (visit 3, study ends).)
- Changes in baseline aggression at 2 and 6 weeks respectively.(Performed at visit 2 (pre treatment), 2 weeks into treatment (performed at distance) and after 6 weeks of treatment (visit 3, study ends).)
- Changes in baseline depressive symptoms and anxiety at 2 and 6 weeks respectively.(Performed at visit 2 (pre treatment), 2 weeks into treatment (performed at distance) and after 6 weeks of treatment (visit 3, study ends).)
- Changes in baseline emotional reactivity at 2 and 6 weeks respectively.(Performed at visit 2 (pre treatment), 2 weeks into treatment (performed at distance) and after 6 weeks of treatment (visit 3, study ends).)
研究者
Mats Holmberg
Chief Physician
Karolinska University Hospital