Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/33708
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dc.contributor.authorNolan, Brendan James-
dc.contributor.authorZwickl, Sav-
dc.contributor.authorLocke, Peter-
dc.contributor.authorZajac, Jeffrey D-
dc.contributor.authorCheung, Ada S-
dc.date2023-
dc.date.accessioned2023-09-13T04:43:30Z-
dc.date.available2023-09-13T04:43:30Z-
dc.date.issued2023-09-05-
dc.identifier.citationJAMA Network Open 2023-09-05; 6(9)en_US
dc.identifier.issn2574-3805-
dc.identifier.urihttps://ahro.austin.org.au/austinjspui/handle/1/33708-
dc.description.abstractTestosterone treatment is a necessary component of care for some transgender and gender-diverse individuals. Observational studies have reported associations between commencement of gender-affirming hormone therapy and improvements in gender dysphoria and depression, but there is a lack of data from randomized clinical trials. To assess the effect of testosterone therapy compared with no treatment on gender dysphoria, depression, and suicidality in transgender and gender-diverse adults seeking masculinization. A 3-month open-label randomized clinical trial was conducted at endocrinology outpatient clinics and primary care clinics specializing in transgender and gender-diverse health in Melbourne, Australia, from November 1, 2021, to July 22, 2022. Participants included transgender and gender-diverse adults aged 18 to 70 years seeking initiation of testosterone therapy. Immediate initiation of testosterone commencement (intervention group) or no treatment (standard care waiting list of 3 months before commencement). This design ensured no individuals would be waiting longer than the time to standard care. The primary outcome was gender dysphoria, as measured by the Gender Preoccupation and Stability Questionnaire. Secondary outcomes included the Patient Health Questionnaire-9 (PHQ-9) to assess depression and the Suicidal Ideation Attributes Scale (SIDAS) to assess suicidality. Questionnaires were undertaken at 0 and 3 months. The evaluable cohort was analyzed. Sixty-four transgender and gender-diverse adults (median [IQR] age, 22.5 [20-27] years) were randomized. Compared with standard care, the intervention group had a decrease in gender dysphoria (mean difference, -7.2 points; 95% CI, -8.3 to -6.1 points; P < .001), a clinically significant decrease in depression (ie, change in score of 5 points on PHQ-9; mean difference, -5.6 points; 95% CI, -6.8 to -4.4 points; P < .001), and a significant decrease in suicidality (mean difference in SIDAS score, -6.5 points; 95% CI, -8.2 to -4.8 points; P < .001). Resolution of suicidality assessed by PHQ-9 item 9 occurred in 11 individuals (52%) with immediate testosterone commencement compared with 1 (5%) receiving standard care (P = .002). Seven individuals reported injection site pain/discomfort and 1 individual reported a transient headache 24 hours following intramuscular administration of testosterone undecanoate. No individual developed polycythemia. In this open-label randomized clinical trial of testosterone therapy in transgender and gender-diverse adults, immediate testosterone compared with no treatment significantly reduced gender dysphoria, depression, and suicidality in transgender and gender-diverse individuals desiring testosterone therapy. ANZCTR Identifier: ACTRN1262100016864.en_US
dc.language.isoeng-
dc.titleEarly Access to Testosterone Therapy in Transgender and Gender-Diverse Adults Seeking Masculinization: A Randomized Clinical Trial.en_US
dc.typeJournal Articleen_US
dc.identifier.journaltitleJAMA Network Openen_US
dc.identifier.affiliationEndocrinologyen_US
dc.identifier.affiliationMedicine (University of Melbourne)en_US
dc.identifier.affiliationEquinox Gender Diverse Clinic, Thorne Harbour Health, Abbotsford, Victoria, Australia.en_US
dc.identifier.affiliationTrans Health Research Group, Department of Medicine (Austin Health), University of Melbourne, Heidelberg, Victoria, Australia.en_US
dc.identifier.doi10.1001/jamanetworkopen.2023.31919en_US
dc.type.contentTexten_US
dc.identifier.pubmedid37676662-
dc.description.volume6-
dc.description.issue9-
dc.description.startpagee2331919-
dc.subject.meshtermssecondaryTestosterone/therapeutic use-
item.languageiso639-1en-
item.openairetypeJournal Article-
item.openairecristypehttp://purl.org/coar/resource_type/c_18cf-
item.fulltextNo Fulltext-
item.grantfulltextnone-
item.cerifentitytypePublications-
crisitem.author.deptEndocrinology-
crisitem.author.deptMedicine (University of Melbourne)-
crisitem.author.deptEndocrinology-
crisitem.author.deptMedicine (University of Melbourne)-
crisitem.author.deptEndocrinology-
crisitem.author.deptMedicine (University of Melbourne)-
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