We are experiencing 4 week turn-around time in review of submissions and resubmissions. We recommend commencing this process concurrently with your ethics submission and allowing at least 8 weeks for registration to be completed from date of first submission. We currently do not have the capacity to expedite reviews.

Note also there are delays to review of updates. We appreciate your patience.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
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

Study type
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

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

Key inclusion criteria
Transfeminine individuals aged 18-70 years.
Minimum age
18 Years
Maximum age
70 Years
Can healthy volunteers participate?
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
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
Other design features
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
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
Name [1] 306663 0
Endocrine Society of Australia
Address [1] 306663 0
145 Macquarie Street
Sydney NSW 2000
Country [1] 306663 0
Primary sponsor type
Austin Health
145 Studley Road
Heidelberg VIC 3084
Secondary sponsor category [1] 307213 0
Name [1] 307213 0
Address [1] 307213 0
Country [1] 307213 0

Ethics approval
Ethics application status
Ethics committee name [1] 306844 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 306844 0
Austin Health
L8 Harold Stokes Building,
145 Studley Road, Heidelberg
PO Box 5555, Victoria, 3084
Ethics committee country [1] 306844 0
Date submitted for ethics approval [1] 306844 0
Approval date [1] 306844 0
Ethics approval number [1] 306844 0

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.
Trial website
Trial related presentations / publications
Public notes

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
Phone 105202 0
Fax 105202 0
Email 105202 0
Contact person for public queries
Name 105203 0
Dr Brendan Nolan
Address 105203 0
Level 2, Centaur Building
Heidelberg Repatriation Hospital
300 Waterdale Road
Heidelberg Heights
VIC 3081
Country 105203 0
Phone 105203 0
Fax 105203 0
Email 105203 0
Contact person for scientific queries
Name 105204 0
Dr Brendan Nolan
Address 105204 0
Level 2, Centaur Building
Heidelberg Repatriation Hospital
300 Waterdale Road
Heidelberg Heights
VIC 3081
Country 105204 0
Phone 105204 0
Fax 105204 0
Email 105204 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results