None listed
Conditions
Brief summary
Transgender men are treated with testosterone to align their physical appearance with their gender identity and improve mental health. Although the current evidence does show improvements in mental health, there is a lack of high-quality data in this field. We will undertake a pragmatic intervention whereby after initial assessment and informed consent, we will randomise individuals to an immediate testosterone therapy compared to a delayed testosterone therapy group (which due to standard care clinic waiting times is an approximately 3 month wait to commence testosterone therapy). We aim to establish the influence of testosterone therapy on gender dysphoria, depression, suicidality and quality of life in transgender men newly commencing testosterone therapy.
Interventions
Testosterone undecanoate 1000mg, intramuscular injection, week 0 and week 6
Transdermal testosterone 1%, transdermal gel, 4 pump actuations daily, from week 0
Transdermal testosterone 5%, transdermal cream, 2mL daily, from week 0
Participants are able to choose testosterone undecanoate or transdermal testosterone as per standard care
Adherence monitored through unused product return
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
Transgender men newly commencing testosterone therapy.
Exclusion criteria
Contraindication to testosterone Elevated haematocrit at baseline Previous testosterone treatment History of major psychiatric disease or psychological condition that may limit understanding and compliance with study requirements Medications for antiplatelet or anticoagulant therapy
Outcome results
None listed