Early Access to Testosterone Therapy in Transgender and Gender-Diverse Adults Seeking Masculinization: A Randomized Clinical Trial
Primary result · Gender dysphoriaResult — go to the resultMean difference −7.2 points 95% CI −8.3 to −6.1Authors' conclusion
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.
Study context
- Population
- Transgender and gender-diverse adults aged 18 to 70 years seeking initiation of testosterone therapy; endocrinology outpatient and primary care clinics, Melbourne, Australia, 2021–2022evaluable cohort analysed
- Participants
- 64 participants
- Comparison
- Immediate testosterone vs no treatment
- Primary endpoint
- Gender dysphoria (Gender Preoccupation and Stability Questionnaire)
- Follow-up
- 3 months
Methodological detailsopen-label
- Open-label
Primary result
Gender dysphoria
Mean difference
−7.2 points
95% CI −8.3 to −6.1
P < 0.001
Immediate testosteronevs Standard care
mean difference −7.2 points (95% CI −8.3 to −6.1); P < 0.001
As reported in the abstract
Secondary outcomes
| Outcome | Mean difference (points) (95% CI) | P value | |
|---|---|---|---|
| Depression (PHQ-9) · 3 monthsClinically significant decrease (change of 5 points) | −5.6 (−6.8 to −4.4) | P < 0.001 | |
| Suicidality (SIDAS) · 3 months | −6.5 (−8.2 to −4.8) | P < 0.001 | |
| −10−505Difference, points (linear scale) |
Resolution of suicidality (PHQ-9 item 9) · 3 months
P = 0.002
Safety
Adverse effects
- Injection site pain/discomfort
- 7 individuals
- Transient headache 24 hours after intramuscular testosterone undecanoate
- 1 individual
- Polycythemia
- 0
Original publication
Early Access to Testosterone Therapy in Transgender and Gender-Diverse Adults Seeking Masculinization: A Randomized Clinical Trial. JAMA Netw Open. Published 5 September 2023. doi:10.
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