Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000022864
Ethics application status
Approved
Date submitted
11/11/2020
Date registered
14/01/2021
Date last updated
14/01/2021
Date data sharing statement initially provided
14/01/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised placebo-controlled trial of low-dose transdermal estrogen in transgender women during surgery
Scientific title
Safety and quality of life of perioperative transdermal estradiol continuation during gender affirmation surgery in transgender women: a randomised placebo-controlled trial
Secondary ID [1] 302758 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Transgender 319706 0
Gender affirmation surgery 319707 0
Thrombosis 319708 0
Condition category
Condition code
Metabolic and Endocrine 317637 317637 0 0
Other endocrine disorders
Blood 317638 317638 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Estradiol gel (Estrogel) 2 pump actuations (1.5mg estradiol) transdermally once daily commencing 4 weeks prior to surgery
Adherence monitored through unused product return
Intervention code [1] 319040 0
Treatment: Drugs
Comparator / control treatment
Placebo gel (Ethanol, Carbomer 980, Trolamine, Purified water) 2 pump actuations daily
Adherence monitored through unused product return
Control group
Placebo

Outcomes
Primary outcome [1] 325681 0
Coagulability of blood, as measured by thromboelastography
Timepoint [1] 325681 0
4 and 6 weeks post-enrolment
Secondary outcome [1] 388750 0
The frequency and severity of hot flushes, as measured using the Hot Flush Rating Scale
Timepoint [1] 388750 0
4 and 6 weeks post-enrolment
Secondary outcome [2] 388751 0
The extent of menopausal symptoms, as measured using the Greene Climacteric Scale
Timepoint [2] 388751 0
4 and 6 weeks post-enrolment
Secondary outcome [3] 388752 0
Patient Health Questionnaire 9 to screen for anxiety and/or depression
Timepoint [3] 388752 0
4 and 6 weeks post-enrolment
Secondary outcome [4] 388753 0
Symptoms of gender dysphoria, as graded by the Gender Preoccupation and Stability Questionnaire
Timepoint [4] 388753 0
4 and 6 weeks post-enrolment
Secondary outcome [5] 388754 0
Serum estradiol concentration
Timepoint [5] 388754 0
4 and 6 weeks post-enrolment

Eligibility
Key inclusion criteria
Transgender women undergoing gender affirmation surgery (vaginoplasty or labioplasty).
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindications to estradiol including estrogen-sensitive malignancy
History of thromboembolic disease
Known thrombophilia
Use of estradiol implant

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
Safety
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. The estimated marginal means across each timepoint plus 95% CI between the groups from baseline to study end will be determined. 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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2021
Actual
Date of last participant enrolment
Anticipated
31/12/2021
Actual
Date of last data collection
Anticipated
18/02/2022
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 17990 0
Masada Private Hospital - East St Kilda
Recruitment postcode(s) [1] 31949 0
3183 - East St Kilda

Funding & Sponsors
Funding source category [1] 307178 0
Charities/Societies/Foundations
Name [1] 307178 0
Endocrine Society of Australia
Country [1] 307178 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Parkville VIC 3010
Country
Australia
Secondary sponsor category [1] 307795 0
None
Name [1] 307795 0
Address [1] 307795 0
Country [1] 307795 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307291 0
Ramsay Health Care NSW | VIC HREC
Ethics committee address [1] 307291 0
Level 8, 154 Pacific Highway
ST LEONARDS NSW2065
Ethics committee country [1] 307291 0
Australia
Date submitted for ethics approval [1] 307291 0
24/09/2019
Approval date [1] 307291 0
20/12/2020
Ethics approval number [1] 307291 0
2019-013

Summary
Brief summary
Despite no clear evidence, transgender women are told to stop their feminising estrogen treatment several weeks before gender surgery, but can cause severe ‘menopausal symptoms’ with hot flushes, depression and distress compounding an already stressful preparation for and recovery from major surgery. This study will assess the safety of continuing estrogen gel around the time of surgery. We hypothesise that estrogen gel will reduce 'menopause symptoms' and improve quality of life, and will be safe to continue around gender surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106710 0
Dr Ada Cheung
Address 106710 0
Level 2, Centaur Building
Heidelberg Repatriation Hospital
300 Waterdale Road
Heidelberg Heights
VIC 3081
Country 106710 0
Australia
Phone 106710 0
+61394962260
Fax 106710 0
Email 106710 0
adac@unimelb.edu.au
Contact person for public queries
Name 106711 0
Dr Brendan Nolan
Address 106711 0
Level 2, Centaur Building
Heidelberg Repatriation Hospital
300 Waterdale Road
Heidelberg Heights
VIC 3081
Country 106711 0
Australia
Phone 106711 0
+61394962260
Fax 106711 0
Email 106711 0
gender-research@unimelb.edu.au
Contact person for scientific queries
Name 106712 0
Dr Brendan Nolan
Address 106712 0
Level 2, Centaur Building
Heidelberg Repatriation Hospital
300 Waterdale Road
Heidelberg Heights
VIC 3081
Country 106712 0
Australia
Phone 106712 0
+61394962260
Fax 106712 0
Email 106712 0
gender-research@unimelb.edu.au

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.