[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100489168":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":38,"locations":48,"responsibleParty":68,"collaborators":42,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":42,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":42,"overallStatus":51,"whyStopped":42,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Karolinska University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active comparator arm","ACTIVE_COMPARATOR","Active treatment",[13],"Drug: Testosterone treatment",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo comparator arm","PLACEBO_COMPARATOR","Placebo treatment",[19],"Other: Placebo treatment",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Testosterone treatment","Cross-sex hormone therapy consisting of intramuscular injection of testosterone undecanoate 250mg\u002Fml. 4ml (total dosage of 1000mg) administered by trained nurse in the gluteal region at visit 1.",[9],[27],"Nebido (3-oxandrostenderivate), testosterone undecanoate",{"type":6,"name":17,"description":29,"armGroupLabels":30,"otherNames":31},"Saline solution. Intramuscular injection of physiological saline solution. 4ml administered by trained nurse in the gluteal region at visit 1.",[15],[32],"Sodium chloride solution",[34],{"name":35,"affiliation":36,"role":37},"Mats Holmberg, MD. PhD.","ANOVA Karolinska sjukhuset","PRINCIPAL_INVESTIGATOR",[39,44],{"name":35,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","+46705266365",null,"mats.holmberg.1@ki.se",{"name":45,"role":40,"phone":46,"phoneExt":42,"email":47},"Anders Hagelin, MD.","+46736265973","anders.hagelin@ki.se",[49],{"facility":50,"status":51,"city":52,"state":42,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Karolinska Universitetssjukhuset, ANOVA","RECRUITING","Stockholm","112 52","Sweden","SE",{"type":57,"coordinates":58},"Point",[59,60],18.06871,59.32938,{"lat":60,"lon":59},[63,65],{"name":64,"role":40,"phone":41,"phoneExt":42,"email":43},"Mats Holmberg, PhD",{"name":66,"role":40,"phone":46,"phoneExt":42,"email":67},"Anders Hagelin, PhD-student","anders.hagelin@regionstockholm.se",{"type":37,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"Mats Holmberg","Chief Physician","100489168","early-mental-response---the-emre-study-100489168",false,"NCT05649605","Early Mental Response - The EMRE Study","Early Mental Response to Hormonal Treatment in Transgender Men - The EMRE Study","EMRE","Inclusion criteria:\n\n1. Well-informed written consent to participate in the study.\n2. Transgender man given the ICD-10 diagnosis of transsexualism.\n3. A desire for complete gender-confirming hormonal treatment.\n4. Approved for Nebido treatment by a clinically responsible Endocrinologist.\n\nExclusion criteria:\n\n1. 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.).\n2. A disability that prevents the patient from fully participating in the study.\n3. Treatment with steroid hormones (androgens, estrogens, progestogens, or continuous treatment with oral corticosteroids within the last three months).\n4. Previous use of hormone preparations without a doctor's prescription.\n5. Laboratory samples significantly outside the normal reference range.\n6. Anamnestic or investigational suspicion of breast cancer or existing or previous liver tumors.\n7. Levels of P-ASAT, P-ALAT, or P-GT at the screening time that are\\> 2 times the reference range.\n8. Hypersensitivity to the active substance or to any of the excipients.\n9. Ongoing pregnancy or wishes for a pregnancy in the near future.","FEMALE","18 Years","99 Years",{"count":83,"type":84},70,"ESTIMATED","INTERVENTIONAL",[87],"NA","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.\n\nSecondary question: Does transgender men´s experience of self-esteem, quality of life, sexual desire, aggression, depression\u002Fanxiety, 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\u002Fsocial 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.",[90,91,92],"Gender Dysphoria","Gender Identity","Gender Issues","2023-03-07",{"date":95,"type":96},"2023-03-08","ACTUAL",{"date":93,"type":96},{"date":99,"type":84},"2026-12-30",{"name":5,"class":6},1]