CompletedPhase 4ACTRN12621000716864

Testosterone for gender dysphoria in transgender men

A randomised controlled trial of testosterone treatment on gender dysphoria, depression, suicidality and quality of life in transgender men


Sponsor

University of Melbourne

Enrollment

74 participants

Start Date

Nov 1, 2021

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 70 Yearss

Inclusion Criteria1

  • Transgender men newly commencing testosterone therapy.

Exclusion Criteria5

  • 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

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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%, transderma

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


Locations(1)

Austin Health - Heidelberg Repatriation Hospital - Heidelberg West

VIC, Australia

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