Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000339954
Ethics application status
Approved
Date submitted
28/02/2020
Date registered
11/03/2020
Date last updated
26/09/2022
Date data sharing statement initially provided
11/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing the effectiveness of testosterone-blocking medications in trans and gender diverse individuals
Scientific title
A randomised double-blind trial comparing the effectiveness of anti-androgen medications in trans and gender diverse individuals
Secondary ID [1] 300635 0
Nil known
Universal Trial Number (UTN)
U1111-1248-7232
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
transgender 316411 0
body composition 316412 0
breast growth 316413 0
Condition category
Condition code
Metabolic and Endocrine 314671 314671 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Estradiol therapy titrated as per 'Çheung AS et al. Position statement on the hormonal management of adult transgender and gender diverse individuals. Med J Aust 2019; 211 (3): 127-133. doi: 10.5694/mja2.50259'
Arm 1: Spironolactone 100mg daily (oral tablet) x 6 months '
Adherence monitored through unused product return
Intervention code [1] 316963 0
Treatment: Drugs
Comparator / control treatment
Estradiol therapy titrated as per 'Çheung AS et al. Position statement on the hormonal management of adult transgender and gender diverse individuals. Med J Aust 2019; 211 (3): 127-133. doi: 10.5694/mja2.50259'
Arm 2: Cyproterone acetate 12.5mg daily (oral tablet) x 6 months
Adherence monitored through unused product return
Control group
Active

Outcomes
Primary outcome [1] 322996 0
Breast growth using measurements of chest and breast circumference & clinical photography (2D frontal and lateral views, 3D scan)
Timepoint [1] 322996 0
6 months post-enrolment in study
Secondary outcome [1] 380482 0
Body composition measured by Dual xray absorptiometry (DXA)
Timepoint [1] 380482 0
6 months post-enrolment
Secondary outcome [2] 380483 0
Serum total testosterone
Timepoint [2] 380483 0
6 months post-enrolment
Secondary outcome [3] 380484 0
Gender preoccupation and dysphoria questionnaire
Timepoint [3] 380484 0
6 months post-enrolment
Secondary outcome [4] 380485 0
Patient Health Questionnaire 9 to screen for depression
Timepoint [4] 380485 0
6 months post-enrolment

Eligibility
Key inclusion criteria
Transgender individuals newly commencing feminising therapy with anti-androgen medication
Minimum age
16 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Androgen deficiency at baseline
Planned orchidectomy within 6 months
Contraindication to treatment with estradiol, spironolactone or cyproterone (e.g. estrogen sensitive cancer, venous thromboembolic events, hyperkalaemia, severe depression)

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Generalised linear mixed model with a restricted maximum likelihood function to determine between group differences in the main outcome measures over time, adjusted for randomisation strata. Further analysis will include outcomes as a quantitative measure, using Generalised additive mixed models to examine non-linear (spline) effects of hormone treatments over time, adjusted for randomisation strata. The estimated marginal means across each timepoint plus 95% CI between the groups from baseline to study end will be determined, and p values <0.05 are considered statistically significant. Following an intention-to-treat protocol, the analysis will include all randomised subjects who are enrolled in the trial

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/08/2020
Actual
31/08/2020
Date of last participant enrolment
Anticipated
1/04/2022
Actual
15/03/2022
Date of last data collection
Anticipated
1/10/2022
Actual
13/09/2022
Sample size
Target
64
Accrual to date
Final
66
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19822 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 34510 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 305058 0
University
Name [1] 305058 0
The University of Melbourne
Country [1] 305058 0
Australia
Funding source category [2] 305059 0
Charities/Societies/Foundations
Name [2] 305059 0
Royal Australian College of Physicians
Country [2] 305059 0
Australia
Funding source category [3] 305110 0
Charities/Societies/Foundations
Name [3] 305110 0
Royal Australasian College of Physicians
Country [3] 305110 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley Rd, Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 305424 0
None
Name [1] 305424 0
Address [1] 305424 0
Country [1] 305424 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305445 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 305445 0
Ethics committee country [1] 305445 0
Australia
Date submitted for ethics approval [1] 305445 0
Approval date [1] 305445 0
02/09/2019
Ethics approval number [1] 305445 0
HREC/44503/Austin-2018

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100414 0
A/Prof Ada Cheung
Address 100414 0
Level 2, Centaur Building
Heidelberg Repatriation Hospital
300 Waterdale Road
Heidelberg Heights
VIC 3081
Country 100414 0
Australia
Phone 100414 0
+613 94962260
Fax 100414 0
Email 100414 0
[email protected]
Contact person for public queries
Name 100415 0
Lachlan Angus
Address 100415 0
Level 2, Centaur Building
Heidelberg Repatriation Hospital
300 Waterdale Road
Heidelberg Heights
VIC 3081
Country 100415 0
Australia
Phone 100415 0
+61 3 94962260
Fax 100415 0
Email 100415 0
[email protected]
Contact person for scientific queries
Name 100416 0
Lachlan Angus
Address 100416 0
Level 2, Centaur Building
Heidelberg Repatriation Hospital
300 Waterdale Road
Heidelberg Heights
VIC 3081
Country 100416 0
Australia
Phone 100416 0
+61 3 94962260
Fax 100416 0
Email 100416 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
deidentified data considered on request
When will data be available (start and end dates)?
Start date 1/1/2021. No end date determined
Available to whom?
collaborating researchers with human research ethics committee approval for proposed analysis
Available for what types of analyses?
any purpose that leads to improvements in patient care
How or where can data be obtained?
on request to principal investigator, Dr Ada Cheung (email: [email protected])


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
SourceTitleYear of PublicationDOI
EmbaseFeminising Gender Affirming Hormone Therapy Prolongs QTc Interval.2023https://dx.doi.org/10.1210/jendso/bvad114.2084
N.B. These documents automatically identified may not have been verified by the study sponsor.