Not Yet RecruitingPhase 4ACTRN12620001364965

Micronised progesterone for sleep in transgender women

Short-term effects of micronised progesterone on sleep quality in transfeminine individuals: a randomised, placebo-controlled cross-over trial


Sponsor

Austin Health

Enrollment

38 participants

Start Date

Jan 4, 2021

Study Type

Interventional

Conditions

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.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 70 Yearss

Inclusion Criteria1

  • Transfeminine individuals aged 18-70 years.

Exclusion Criteria10

  • Contraindications to micronised progesterone.
  • Sunflower seed allergy.
  • Known, suspected, or history of breast cancer.
  • Active deep vein thrombosis, pulmonary embolism or history of these conditions.
  • Active arterial thromboembolic disease or history of these conditions.
  • Known liver dysfunction or disease.
  • Recreational drug use, alcohol dependence, known HIV/AIDS or any disease that is
  • likely lead to serious illness or death within the study period.
  • Inability to understand sufficient English to provide informed consent or participate in
  • the trial.

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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

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


Locations(1)

Austin Health - Heidelberg Repatriation Hospital - Heidelberg West

VIC, Australia

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