Comparing the effectiveness of testosterone-blocking medications in trans and gender diverse individuals

A randomised double-blind trial comparing the effectiveness of anti-androgen medications in trans and gender diverse individuals

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12620000339954

Enrollment

Registered

2020-03-11

Start date

2020-08-31

Completion date

2022-03-15

Last updated

2022-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Transgender people desiring feminisation are often treated with estrogens and testosterone blocking medication. Spironolactone and cyproterone acetate are commonly used testosterone blocking medications, though it is unclear which is better at causing feminisation. This study will compare the effects of spironolactone and cyproterone acetate on breast growth, body composition and testosterone levels.

Interventions

Estradiol therapy titrated as per 'Çheung AS et al. Position statement on the hormonal management of adult transgender and gender diverse individuals. Med J Aust 2019; 211 (3): 127-133. doi: 10.5694/mja2.50259' Arm 1: Spironolactone 100mg daily (oral tablet) x 6 months ' Adherence monitored through unused product return

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

16 Years to 80 Years

Healthy volunteers

Inclusion criteria

Transgender individuals newly commencing feminising therapy with anti-androgen medication

Exclusion criteria

Androgen deficiency at baseline Planned orchidectomy within 6 months Contraindication to treatment with estradiol, spironolactone or cyproterone (e.g. estrogen sensitive cancer, venous thromboembolic events, hyperkalaemia, severe depression)

Outcome results