None listed
Conditions
Brief summary
Low-dose testosterone therapy is used by an increasing number of trans people, particularly those with a non-binary gender. However, very little is known about the impact of low-dose testosterone on gender dysphoria, gender euphoria, mental health and physiological outcomes. Currently, in our Austin Health gender clinic, following initial assessment of suitability and informed consent, due to large demand for appointments, there is a minimum 3-month waitlist prior to initiation of gender affirming hormone therapy. This is standard care. We will undertake a pragmatic intervention whereby after initial assessment and informed consent, we will randomise individuals to immediate low-dose testosterone therapy or delayed testosterone therapy (commencement of low-dose testosterone after the standard care 3-month waiting list). This will be followed by a 12-month extended follow-up following initiation of testosterone, At 6 months post-commencement of the intervention, a subgroup of participants from both groups will be invited to participate in semi-structured interviews with one of the study investigators. These interviews will explore the participants' motivations and goals for initiating low-dose testosterone, as well as the impact of testosterone on their gender dysphoria, gender euphoria, mental health and quality of life. This project is a trial of trans people newly commencing low-dose testosterone therapy. We aim to establish the influence of low-dose testosterone on gender dysphoria, gender euphoria, depression, suicidality and quality of life. We also aim to gain a greater understanding of the impact of low-dose testosterone on serum testosterone concentrations, and common biochemistry markers. In particular, we hypothesise that immediate access to low-dose testosterone, compared to no treatment, will reduce gender dysphoria, depression and suicidality, improve quality of life, and increase gender euphoria. We also hypothesise that low-dose testosterone will increase testosterone levels to an intermediate range between those expected for cisgender men and cisgender women.
Interventions
Transdermal testosterone 1%, transdermal gel, 12.5mg per pump actuation, 2 pump actuations daily, from week 0 to week 12. Adherence monitored through patient calendar/ diary.
Followed by a 12-month extended follow-up post-initiation of testosterone.
Sponsors
University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Trans people newly commencing low-dose testosterone, who: 1. Are deemed suitable for commencement using the informed consent model of care, and 2. Plan to remain on low-dose testosterone for at least 3 months (from the time of enrolment in the trial)
Exclusion criteria
1. Contraindication to testosterone 2. Previous testosterone treatment 3. Significant mental health conditions or cognitive impairment compromising the ability to provide informed consent
Outcome results
None listed