Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000716864
Ethics application status
Approved
Date submitted
19/04/2021
Date registered
8/06/2021
Date last updated
28/02/2023
Date data sharing statement initially provided
8/06/2021
Date results information initially provided
28/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Testosterone for gender dysphoria in transgender men
Scientific title
A randomised controlled trial of testosterone treatment on gender dysphoria, depression, suicidality and quality of life in transgender men
Secondary ID [1] 304003 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Transgender health 321617 0
Gender dysphoria 321618 0
Depression 321619 0
Suicide 321620 0
Condition category
Condition code
Metabolic and Endocrine 319361 319361 0 0
Other endocrine disorders
Mental Health 319362 319362 0 0
Depression
Mental Health 319363 319363 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 320313 0
Treatment: Drugs
Comparator / control treatment
12 week standard care delay to commencement due to waitlist:
Testosterone undecanoate 1000mg, intramuscular injection, week 12 and week 18
Transdermal testosterone 1%, transdermal gel, 4 pump actuations daily, from week 12
Transdermal testosterone 5%, transdermal cream, 2mL daily, from week 12
Participants are able to choose testosterone undecanoate or transdermal testosterone as per standard care
Adherence monitored through unused product return
Control group
Active

Outcomes
Primary outcome [1] 327225 0
Symptoms of gender dysphoria, as graded by the Gender Preoccupation and Stability Questionnaire
Timepoint [1] 327225 0
12 weeks post-enrolment
Secondary outcome [1] 394282 0
Psychological distress, as graded by the Patient Health Questionnaire 9
Timepoint [1] 394282 0
12 weeks post-enrolment
Secondary outcome [2] 394283 0
Suicidality, as graded by the Suicidal Ideation Attributes Scale (SI-DAS)
Timepoint [2] 394283 0
12 weeks post-enrolment
Secondary outcome [3] 394284 0
Quality of life, as graded by the EQ-5D-5L
Timepoint [3] 394284 0
12 weeks post-enrolment

Eligibility
Key inclusion criteria
Transgender men newly commencing testosterone therapy.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation performed by third party off site using schedule
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis of covariance (ANCOVA) will be used to determine between group differences in the main outcome measures over time, adjusted for the value at baseline. P values <0.05 are considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2021
Actual
1/11/2021
Date of last participant enrolment
Anticipated
Actual
22/07/2022
Date of last data collection
Anticipated
Actual
5/10/2022
Sample size
Target
74
Accrual to date
Final
64
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19161 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment postcode(s) [1] 33732 0
3081 - Heidelberg West

Funding & Sponsors
Funding source category [1] 308384 0
Charities/Societies/Foundations
Name [1] 308384 0
Endocrine Society of Australia
Country [1] 308384 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Parkville VIC 3010
Country
Australia
Secondary sponsor category [1] 309213 0
None
Name [1] 309213 0
Address [1] 309213 0
Country [1] 309213 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308349 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 308349 0
Austin Health
L8 Harold Stokes Building,
145 Studley Road, Heidelberg
PO Box 5555, Victoria, 3084
Ethics committee country [1] 308349 0
Australia
Date submitted for ethics approval [1] 308349 0
08/06/2021
Approval date [1] 308349 0
09/09/2021
Ethics approval number [1] 308349 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110402 0
Dr Ada Cheung
Address 110402 0
Level 2, Centaur Building
Heidelberg Repatriation Hospital
300 Waterdale Road
Heidelberg Heights
VIC 3081
Country 110402 0
Australia
Phone 110402 0
+61 394962260
Fax 110402 0
Email 110402 0
[email protected]
Contact person for public queries
Name 110403 0
Dr Brendan Nolan
Address 110403 0
Level 2, Centaur Building
Heidelberg Repatriation Hospital
300 Waterdale Road
Heidelberg Heights
VIC 3081
Country 110403 0
Australia
Phone 110403 0
+61 394962260
Fax 110403 0
Email 110403 0
[email protected]
Contact person for scientific queries
Name 110404 0
Dr Brendan Nolan
Address 110404 0
Level 2, Centaur Building
Heidelberg Repatriation Hospital
300 Waterdale Road
Heidelberg Heights
VIC 3081
Country 110404 0
Australia
Phone 110404 0
+61 394962260
Fax 110404 0
Email 110404 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.