Trial Review

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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
Scientific title
Short-term effects of micronised progesterone on sleep quality in transfeminine individuals: a
randomised, placebo-controlled cross-over trial
Secondary ID [1] 302240 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Transgender health 318954 0
Sleep disturbance 318955 0
Anxiety 318956 0
Condition category
Condition code
Metabolic and Endocrine 316927 316927 0 0
Other endocrine disorders
Neurological 317769 317769 0 0
Studies of the normal brain and nervous system
Mental Health 317770 317770 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 318529 0
Treatment: Drugs
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
Control group
Placebo

Outcomes
Primary outcome [1] 325032 0
Sleep, as measured by Pittsburgh Sleep Quality Index (PSQI)
Timepoint [1] 325032 0
Week 4 and week 8 (primary endpoint) post-intervention commencement
Secondary outcome [1] 386592 0
Psychological distress, as measured by K10
Timepoint [1] 386592 0
Week 4 and week 8 post-intervention commencement
Secondary outcome [2] 386593 0
Serum total testosterone concentration, as measured by blood sample
Timepoint [2] 386593 0
Week 4 and week 8 post-intervention commencement

Eligibility
Key inclusion criteria
Transfeminine individuals aged 18-70 years.
Minimum age
18 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
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.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/01/2021
Actual
Date of last participant enrolment
Anticipated
30/04/2022
Actual
Date of last data collection
Anticipated
30/06/2022
Actual
Sample size
Target
38
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 17439 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment postcode(s) [1] 31168 0
3081 - Heidelberg West

Funding & Sponsors
Funding source category [1] 306663 0
Charities/Societies/Foundations
Name [1] 306663 0
Endocrine Society of Australia
Country [1] 306663 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley Road
Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 307213 0
None
Name [1] 307213 0
Address [1] 307213 0
Country [1] 307213 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306844 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 306844 0
Ethics committee country [1] 306844 0
Australia
Date submitted for ethics approval [1] 306844 0
Approval date [1] 306844 0
20/10/2020
Ethics approval number [1] 306844 0
HREC/61308/Austin-2020

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

Contacts
Principal investigator
Name 105202 0
Dr Ada Cheung
Address 105202 0
Level 2, Centaur Building
Heidelberg Repatriation Hospital
300 Waterdale Road
Heidelberg Heights
VIC 3081
Country 105202 0
Australia
Phone 105202 0
+61394962260
Fax 105202 0
Email 105202 0
adac@unimelb.edu.au
Contact person for public queries
Name 105203 0
Brendan Nolan
Address 105203 0
Level 2, Centaur Building
Heidelberg Repatriation Hospital
300 Waterdale Road
Heidelberg Heights
VIC 3081
Country 105203 0
Australia
Phone 105203 0
+61394962260
Fax 105203 0
Email 105203 0
gender-research@unimelb.edu.au
Contact person for scientific queries
Name 105204 0
Brendan Nolan
Address 105204 0
Level 2, Centaur Building
Heidelberg Repatriation Hospital
300 Waterdale Road
Heidelberg Heights
VIC 3081
Country 105204 0
Australia
Phone 105204 0
+61394962260
Fax 105204 0
Email 105204 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.