WithdrawnPhase 4ACTRN12621000022864

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


Sponsor

University of Melbourne

Enrollment

32 participants

Start Date

Feb 1, 2021

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 40 Yearss

Inclusion Criteria1

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

Exclusion Criteria4

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

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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

Estradiol gel (Estrogel) 2 pump actuations (1.5mg estradiol) transdermally once daily commencing 4 weeks prior to surgery Adherence monitored through unused product return


Locations(1)

Masada Private Hospital - East St Kilda

VIC, Australia

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