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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
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Scientific title
A randomised double-blind trial comparing the effectiveness of anti-androgen medications in trans and gender diverse individuals
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Secondary ID [1]
300635
0
Nil known
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Universal Trial Number (UTN)
U1111-1248-7232
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
transgender
316411
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body composition
316412
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breast growth
316413
0
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Condition category
Condition code
Metabolic and Endocrine
314671
314671
0
0
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Other endocrine disorders
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
316963
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Treatment: Drugs
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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
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Control group
Active
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Outcomes
Primary outcome [1]
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Breast growth using measurements of chest and breast circumference & clinical photography (2D frontal and lateral views, 3D scan)
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Assessment method [1]
322996
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Timepoint [1]
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6 months post-enrolment in study
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Secondary outcome [1]
380482
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Body composition measured by Dual xray absorptiometry (DXA)
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Assessment method [1]
380482
0
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Timepoint [1]
380482
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6 months post-enrolment
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Secondary outcome [2]
380483
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Serum total testosterone
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Assessment method [2]
380483
0
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Timepoint [2]
380483
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6 months post-enrolment
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Secondary outcome [3]
380484
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Gender preoccupation and dysphoria questionnaire
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Assessment method [3]
380484
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Timepoint [3]
380484
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6 months post-enrolment
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Secondary outcome [4]
380485
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Patient Health Questionnaire 9 to screen for depression
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Assessment method [4]
380485
0
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Timepoint [4]
380485
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6 months post-enrolment
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Eligibility
Key inclusion criteria
Transgender individuals newly commencing feminising therapy with anti-androgen medication
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Minimum age
16
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation performed by third party off site using schedule
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Efficacy
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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
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
31/08/2020
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Actual
31/08/2020
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Date of last participant enrolment
Anticipated
1/04/2022
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Actual
15/03/2022
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Date of last data collection
Anticipated
1/10/2022
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Actual
13/09/2022
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Sample size
Target
64
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Accrual to date
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Final
66
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
19822
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Austin Health - Austin Hospital - Heidelberg
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Recruitment postcode(s) [1]
34510
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3084 - Heidelberg
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Funding & Sponsors
Funding source category [1]
305058
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University
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Name [1]
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The University of Melbourne
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Address [1]
305058
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Parkville VIC 3010
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Country [1]
305058
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Australia
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Funding source category [2]
305059
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Charities/Societies/Foundations
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Name [2]
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Royal Australian College of Physicians
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Address [2]
305059
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2/417 St Kilda Rd, Melbourne VIC 3004
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Country [2]
305059
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Australia
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Funding source category [3]
305110
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Charities/Societies/Foundations
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Name [3]
305110
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Royal Australasian College of Physicians
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Address [3]
305110
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2/417 St Kilda Rd, Melbourne VIC 3004
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Country [3]
305110
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Australia
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Primary sponsor type
Hospital
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Name
Austin Health
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Address
145 Studley Rd, Heidelberg VIC 3084
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Country
Australia
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Secondary sponsor category [1]
305424
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None
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Name [1]
305424
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Address [1]
305424
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Country [1]
305424
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
305445
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Austin Health Human Research Ethics Committee
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Ethics committee address [1]
305445
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Office for Research Level 8, Harold Stokes Building Austin Health PO Box 5555 Heidelberg Victoria 3084
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Ethics committee country [1]
305445
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Australia
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Date submitted for ethics approval [1]
305445
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Approval date [1]
305445
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02/09/2019
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Ethics approval number [1]
305445
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HREC/44503/Austin-2018
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Summary
Brief summary
Transgender people desiring feminisation are often treated with estrogens and testosterone blocking medication. Spironolactone and cyproterone acetate are commonly used testosterone blocking medications, though it is unclear which is better at causing feminisation. This study will compare the effects of spironolactone and cyproterone acetate on breast growth, body composition and testosterone levels.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Ada Cheung
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Address
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Level 2, Centaur Building
Heidelberg Repatriation Hospital
300 Waterdale Road
Heidelberg Heights
VIC 3081
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Country
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Australia
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Phone
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+613 94962260
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Fax
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Email
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gender-research@unimelb.edu.au
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Contact person for public queries
Name
100415
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Lachlan Angus
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Address
100415
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Level 2, Centaur Building
Heidelberg Repatriation Hospital
300 Waterdale Road
Heidelberg Heights
VIC 3081
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Country
100415
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Australia
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Phone
100415
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+61 3 94962260
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Fax
100415
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Email
100415
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anti-androgen@unimelb.edu.au
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Contact person for scientific queries
Name
100416
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Lachlan Angus
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Address
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Level 2, Centaur Building
Heidelberg Repatriation Hospital
300 Waterdale Road
Heidelberg Heights
VIC 3081
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Country
100416
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Australia
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Phone
100416
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+61 3 94962260
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Fax
100416
0
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Email
100416
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anti-androgen@unimelb.edu.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
deidentified data considered on request
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When will data be available (start and end dates)?
Start date 1/1/2021. No end date determined
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Available to whom?
collaborating researchers with human research ethics committee approval for proposed analysis
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Available for what types of analyses?
any purpose that leads to improvements in patient care
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How or where can data be obtained?
on request to principal investigator, Dr Ada Cheung (email: adac@unimelb.edu.au)
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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
Source
Title
Year of Publication
DOI
Embase
Feminising Gender Affirming Hormone Therapy Prolongs QTc Interval.
2023
https://dx.doi.org/10.1210/jendso/bvad114.2084
N.B. These documents automatically identified may not have been verified by the study sponsor.
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