None listed
Conditions
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.
Interventions
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
Sponsors
Austin Health
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Transfeminine individuals aged 18-70 years.
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.
Outcome results
None listed