A randomised placebo-controlled trial of low-dose transdermal estrogen in transgender women during surgery

Safety and quality of life of perioperative transdermal estradiol continuation during gender affirmation surgery in transgender women: a randomised placebo-controlled trial

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12621000022864

Enrollment

Registered

2021-01-14

Start date

2021-02-01

Completion date

2021-12-31

Last updated

2025-09-08

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

Conditions

None listed

Brief summary

Despite no clear evidence, transgender women are told to stop their feminising estrogen treatment several weeks before gender surgery, but can cause severe ‘menopausal symptoms’ with hot flushes, depression and distress compounding an already stressful preparation for and recovery from major surgery. This study will assess the safety of continuing estrogen gel around the time of surgery. We hypothesise that estrogen gel will reduce 'menopause symptoms' and improve quality of life, and will be safe to continue around gender surgery.

Interventions

Estradiol gel (Estrogel) 2 pump actuations (1.5mg estradiol) transdermally once daily commencing 4 weeks prior to surgery 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

18 Years to 40 Years

Healthy volunteers

Inclusion criteria

Transgender women undergoing gender affirmation surgery (vaginoplasty or labioplasty).

Exclusion criteria

Contraindications to estradiol including estrogen-sensitive malignancy History of thromboembolic disease Known thrombophilia Use of estradiol implant

Outcome results