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Trial registered on ANZCTR
Registration number
ACTRN12620001364965
Ethics application status
Approved
Date submitted
26/10/2020
Date registered
18/12/2020
Date last updated
18/12/2020
Date data sharing statement initially provided
18/12/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
Micronised progesterone for sleep in transgender women
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Scientific title
Short-term effects of micronised progesterone on sleep quality in transfeminine individuals: a
randomised, placebo-controlled cross-over trial
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Secondary ID [1]
302240
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Nil known
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Universal Trial Number (UTN)
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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 health
318954
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Sleep disturbance
318955
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Anxiety
318956
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Condition category
Condition code
Metabolic and Endocrine
316927
316927
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0
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Other endocrine disorders
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Neurological
317769
317769
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0
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Studies of the normal brain and nervous system
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Mental Health
317770
317770
0
0
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Studies of normal psychology, cognitive function and behaviour
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Micronised progesterone 300mg (3 x 100mg), oral capsule, daily for 1 month
Adherence monitored through unused product return
There is no intervening wash out period between treatments
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Intervention code [1]
318529
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Treatment: Drugs
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Comparator / control treatment
Placebo - identical capsules composed of sunflower oil, soybean lecithin, gelatin, glycerol, titanium dioxide and purified water
Adherence monitored through unused product return
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Control group
Placebo
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Outcomes
Primary outcome [1]
325032
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Sleep, as measured by Pittsburgh Sleep Quality Index (PSQI)
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Assessment method [1]
325032
0
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Timepoint [1]
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Week 4 and week 8 (primary endpoint) post-intervention commencement
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Secondary outcome [1]
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Psychological distress, as measured by K10
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Assessment method [1]
386592
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Timepoint [1]
386592
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Week 4 and week 8 post-intervention commencement
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Secondary outcome [2]
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Serum total testosterone concentration, as measured by blood sample
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Assessment method [2]
386593
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Timepoint [2]
386593
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Week 4 and week 8 post-intervention commencement
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Eligibility
Key inclusion criteria
Transfeminine individuals aged 18-70 years.
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Contraindications to micronised progesterone.
2. Sunflower seed allergy.
3. Known, suspected, or history of breast cancer.
4. Active deep vein thrombosis, pulmonary embolism or history of these conditions.
5. Active arterial thromboembolic disease or history of these conditions.
6. Known liver dysfunction or disease.
7. Recreational drug use, alcohol dependence, known HIV/AIDS or any disease that is
likely lead to serious illness or death within the study period.
8. Inability to understand sufficient English to provide informed consent or participate in
the trial.
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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)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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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
Crossover
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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
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
4/01/2021
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Actual
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Date of last participant enrolment
Anticipated
30/04/2022
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Actual
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Date of last data collection
Anticipated
30/06/2022
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Actual
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Sample size
Target
38
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
17439
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Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
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Recruitment postcode(s) [1]
31168
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3081 - Heidelberg West
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Funding & Sponsors
Funding source category [1]
306663
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Charities/Societies/Foundations
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Name [1]
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Endocrine Society of Australia
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Address [1]
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145 Macquarie Street
Sydney NSW 2000
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Country [1]
306663
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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 Road
Heidelberg VIC 3084
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Country
Australia
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Secondary sponsor category [1]
307213
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None
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Name [1]
307213
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Address [1]
307213
0
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Country [1]
307213
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
306844
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Austin Health Human Research Ethics Committee
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Ethics committee address [1]
306844
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Austin Health L8 Harold Stokes Building, 145 Studley Road, Heidelberg PO Box 5555, Victoria, 3084
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Ethics committee country [1]
306844
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Australia
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Date submitted for ethics approval [1]
306844
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Approval date [1]
306844
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20/10/2020
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Ethics approval number [1]
306844
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HREC/61308/Austin-2020
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Summary
Brief summary
Transgender individuals seeking feminisation (transfeminine individuals) are treated with estrogen and anti-androgen (testosterone blocker) to align their physical appearance with their gender identity. There has been increasing interest in the potential use of progesterone for transfeminine individuals, given anecdotal reports of improved mood and breast development. This randomised placebo-controlled cross-over trial is a trial of micronised progesterone in transfeminine individuals treated with estradiol therapy. We aim to establish the influence of progesterone on sleep, psychological distress and total testosterone concentration.
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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
105202
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Dr 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
105202
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Australia
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Phone
105202
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+61394962260
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Fax
105202
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Email
105202
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adac@unimelb.edu.au
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Contact person for public queries
Name
105203
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Brendan Nolan
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Address
105203
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Level 2, Centaur Building
Heidelberg Repatriation Hospital
300 Waterdale Road
Heidelberg Heights
VIC 3081
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Country
105203
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Australia
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Phone
105203
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+61394962260
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Fax
105203
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Email
105203
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gender-research@unimelb.edu.au
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Contact person for scientific queries
Name
105204
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Brendan Nolan
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Address
105204
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Level 2, Centaur Building
Heidelberg Repatriation Hospital
300 Waterdale Road
Heidelberg Heights
VIC 3081
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Country
105204
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Australia
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Phone
105204
0
+61394962260
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Fax
105204
0
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Email
105204
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gender-research@unimelb.edu.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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
No additional documents have been identified.
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