Not Yet RecruitingPhase 4ACTRN12620001130954

Progesterone for transgender women

Effect of micronised progesterone on sleep in transfeminine individuals: a prospective case-control study


Sponsor

Austin Health

Enrollment

38 participants

Start Date

Nov 4, 2020

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 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.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 70 Yearss

Inclusion Criteria1

  • Transfeminine individuals aged 18-70 years treated with estradiol for at least six months.

Exclusion Criteria9

  • Contraindications to micronised progesterone.
  • History of orchidectomy.
  • 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 100mg, oral capsule, daily for 3 months Adherence monitored through unused product return Group allocation is determined by participants' choice

Micronised progesterone 100mg, oral capsule, daily for 3 months Adherence monitored through unused product return Group allocation is determined by participants' choice


Locations(1)

Austin Health - Heidelberg Repatriation Hospital - Heidelberg West

VIC, Australia

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