Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001130954
Ethics application status
Approved
Date submitted
3/09/2020
Date registered
30/10/2020
Date last updated
30/10/2020
Date data sharing statement initially provided
30/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Progesterone for transgender women
Scientific title
Effect of micronised progesterone on sleep in transfeminine individuals: a prospective case-control study
Secondary ID [1] 301582 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Transgender 317953 0
Sleep 317954 0
Anxiety 317955 0
Condition category
Condition code
Metabolic and Endocrine 315988 315988 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Micronised progesterone 100mg, oral capsule, daily for 3 months

Adherence monitored through unused product return

Group allocation is determined by participants' choice
Intervention code [1] 317875 0
Treatment: Drugs
Comparator / control treatment
Active control, standard of care anti-androgen therapy (cyproterone acetate 12.5-50mg, oral tablet, daily or spironolactone 100-200mg, oral tablet, daily)
Control group
Active

Outcomes
Primary outcome [1] 324190 0
Sleep, as measured by Pittsburgh Sleep Quality Index (PSQI)
Timepoint [1] 324190 0
3 months post-intervention commencement
Secondary outcome [1] 383968 0
Psychological distress (measured by K10)
Timepoint [1] 383968 0
3 months post-intervention commencement
Secondary outcome [2] 383969 0
Breast development assessed using Tanner stage
Timepoint [2] 383969 0
3 months post-intervention commencement

Eligibility
Key inclusion criteria
Transfeminine individuals aged 18-70 years treated with estradiol for at least six months.
Minimum age
18 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Contraindications to micronised progesterone.
2. History of orchidectomy.
3. Sunflower seed allergy.
4. Known, suspected, or history of breast cancer.
5. Active deep vein thrombosis, pulmonary embolism or history of these conditions.
6. Active arterial thromboembolic disease or history of these conditions.
7. Known liver dysfunction or disease.
8. Recreational drug use, alcohol dependence, known HIV/AIDS or any disease that is likely lead to serious illness or death within the study period.
9. Inability to understand sufficient English to provide informed consent or participate in the trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
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
4/11/2020
Actual
Date of last participant enrolment
Anticipated
30/09/2021
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
38
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16938 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment postcode(s) [1] 30596 0
3081 - Heidelberg West

Funding & Sponsors
Funding source category [1] 306008 0
Other Collaborative groups
Name [1] 306008 0
Trans Health Research
Country [1] 306008 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley Road
Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 306471 0
None
Name [1] 306471 0
Address [1] 306471 0
Country [1] 306471 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306244 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 306244 0
Austin Health
L8 Harold Stokes Building,
145 Studley Road, Heidelberg
PO Box 5555, Victoria, 3084
Ethics committee country [1] 306244 0
Australia
Date submitted for ethics approval [1] 306244 0
29/01/2020
Approval date [1] 306244 0
03/09/2020
Ethics approval number [1] 306244 0
HREC/59822/Austin-2020

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 project 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 breast development.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103222 0
Dr Ada Cheung
Address 103222 0
Level 2, Centaur Building
Heidelberg Repatriation Hospital
300 Waterdale Road
Heidelberg Heights
VIC 3081
Country 103222 0
Australia
Phone 103222 0
+61 3 9496 2260
Fax 103222 0
Email 103222 0
[email protected]
Contact person for public queries
Name 103223 0
Dr Brendan Nolan
Address 103223 0
Level 2, Centaur Building
Heidelberg Repatriation Hospital
300 Waterdale Road
Heidelberg Heights
VIC 3081
Country 103223 0
Australia
Phone 103223 0
+61 3 9496 2260
Fax 103223 0
Email 103223 0
[email protected]
Contact person for scientific queries
Name 103224 0
Dr Brendan Nolan
Address 103224 0
Level 2, Centaur Building
Heidelberg Repatriation Hospital
300 Waterdale Road
Heidelberg Heights
VIC 3081
Country 103224 0
Australia
Phone 103224 0
+61 3 9496 2260
Fax 103224 0
Email 103224 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseEffects of low-dose oral micronised progesterone on sleep, psychological distress, and breast development in transgender individuals undergoing feminising hormone therapy: a prospective controlled study.2022https://dx.doi.org/10.1530/EC-22-0170
N.B. These documents automatically identified may not have been verified by the study sponsor.