Dataset Information

Early Access to Testosterone Therapy in Transgender and Gender-Diverse Adults Seeking Masculinization: A Randomized Clinical Trial.

ABSTRACT:

Importance

Testosterone 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.

Objective

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.

Design, setting, and participants

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.

Interventions

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.

Main outcomes and measures

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.

Results

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.

Conclusions and relevance

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.

Trial registration

ANZCTR Identifier: ACTRN1262100016864.

SUBMITTER: Nolan BJ

PROVIDER: S-EPMC10485726 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Early Access to Testosterone Therapy in Transgender and Gender-Diverse Adults Seeking Masculinization: A Randomized Clinical Trial.

Nolan Brendan J BJ Zwickl Sav S Locke Peter P Zajac Jeffrey D JD Cheung Ada S AS

JAMA network open 20230905 9

<h4>Importance</h4>Testosterone 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.<h4>Objective</h4>To assess the effect of testosterone therapy compared with no treatment on gender dysphoria, depression, and suicidality in transgender ...[more]

PMID: 37676662

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Project description:ImportanceLimited prior research suggests that transgender and gender diverse (TGD) people may have higher mortality rates than cisgender people.ObjectiveTo estimate overall and cause-specific mortality among TGD persons compared with cisgender persons.Design, setting, and participantsThis population-based cohort study used data from general practices in England contributing to the UK's Clinical Practice Research Datalink GOLD and Aurum databases. Transfeminine (assigned male at birth) and transmasculine (assigned female at birth) individuals were identified using diagnosis codes for gender incongruence, between 1988 and 2019, and were matched to cisgender men and women according to birth year, practice, and practice registration date and linked to the Office of National Statistics death registration. Data analysis was performed from February to June 2022.Main outcomes and measuresCause-specific mortality counts were calculated for categories of disease as defined by International Statistical Classification of Diseases and Related Health Problems, Tenth Revision chapters. Overall and cause-specific mortality rate ratios (MRRs) were estimated using Poisson models, adjusted for index age, index year, race and ethnicity, Index of Multiple Deprivation, smoking status, alcohol use, and body mass index.ResultsA total of 1951 transfeminine (mean [SE] age, 36.90 [0.34] years; 1801 White [92.3%]) and 1364 transmasculine (mean [SE] age, 29.20 [0.36] years; 1235 White [90.4%]) individuals were matched with 68 165 cisgender men (mean [SE] age, 33.60 [0.05] years; 59 136 White [86.8%]) and 68 004 cisgender women (mean [SE] age, 33.50 [0.05] years; 57 762 White [84.9%]). The mortality rate was 528.11 deaths per 100 000 person-years (102 deaths) for transfeminine persons, 325.86 deaths per 100 000 person-years (34 deaths) for transmasculine persons, 315.32 deaths per 100 000 person-years (1951 deaths) for cisgender men, and 260.61 deaths per 100 000 person-years (1608 deaths) for cisgender women. Transfeminine persons had a higher overall mortality risk compared with cisgender men (MRR, 1.34; 95% CI, 1.06-1.68) and cisgender women (MRR, 1.60; 95% CI, 1.27-2.01). For transmasculine persons, the overall MMR was 1.43 (95% CI, 0.87-2.33) compared with cisgender men and was 1.75 (95% CI, 1.08-2.83) compared with cisgender women. Transfeminine individuals had lower cancer mortality than cisgender women (MRR, 0.52; 95% CI, 0.32-0.83) but an increased risk of external causes of death (MRR, 1.92; 95% CI, 1.05-3.50). Transmasculine persons had higher mortality from external causes of death than cisgender women (MRR, 2.77; 95% CI, 1.15-6.65). Compared with cisgender men, neither transfeminine nor transmasculine adults had a significantly increased risk of deaths due to external causes.Conclusions and relevanceIn this cohort study of primary care data, TGD persons had elevated mortality rates compared with cisgender persons, particularly for deaths due to external causes. Further research is needed to examine how minority stress may be contributing to deaths among TGD individuals to reduce mortality.

Dataset Information

Early Access to Testosterone Therapy in Transgender and Gender-Diverse Adults Seeking Masculinization: A Randomized Clinical Trial.

Importance

Objective

Design, setting, and participants

Interventions

Main outcomes and measures

Results

Conclusions and relevance

Trial registration

Publications

Early Access to Testosterone Therapy in Transgender and Gender-Diverse Adults Seeking Masculinization: A Randomized Clinical Trial.

Similar Datasets

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