None listed
Conditions
Brief summary
We aim to study the levels of hormones and the clotting tendency of blood whilst a patient is on oral oestrogen and compare it to when they are on sublingual oestrogen. This will help us gain a better understanding of the comparative risk of a VTE whilst on sublingual oestrogen and the efficacy of sublingual oestrogen for transgender women. At this stage, we are hoping to include about 30 trans women on feminising gender affirming hormone therapy.
Interventions
comparison of coagulation profile of oral and sublingual routes of administration of oestradiol for gender affirming hormonal therapy in transgender females.
intervention: sublingual administration of oestradiol for gender affirming hormonal therapy. oestradiol (2 mg, Zumenon®, once daily orally for three months)
-drug adherence will be monitored via serum oestradiol levels on clinical review
patients will crossover from control to intervention arm or intervention to control arm based on a ran
comparison of coagulation profile of oral and sublingual routes of administration of oestradiol for gender affirming hormonal therapy in transgender females. intervention: sublingual administration of oestradiol for gender affirming hormonal therapy. oestradiol (2 mg, Zumenon®, once daily orally for three months) -drug adherence will be monitored via serum oestradiol levels on clinical review patients will crossover from control to intervention arm or intervention to control arm based on a randomisation schedule there is no washout period between crossover, patient will be on given gender affirming therapy for 3 months to assess steady state VTE risk
Sponsors
Rita Upreti - Monash health
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18 to 40 years old 2. currently on or commencing prescribed oestrogen as feminising gender affirming hormone therapy
Exclusion criteria
1. Patients who are taking moderate to strong CYP enzyme inducers or inhibitors medications or supplements 2. Known liver impairment (defined as >3 times upper limit of normal liver function tests) 3. Significant alcohol intake. This is defined as alcohol intake that exceeds 10 standard drinks a week and/or 4 standard drinks on any one day 4. Patients with known Haemophilic conditions 5. Patients with pro-thrombotic conditions including inherited and acquired thrombophilia, myeloproliferative neoplasm, previous history of venous or arterial thromboembolism 6. Patients currently on anticoagulant and/or antiplatelet therapy or other medications which are deemed by the principal investigator to influence an individual’s coagulation profile (apart from oestrogen therapy) 7. Active malignancy 8. Renal impairment where eGFR <30ml/min/1.73m2 9. Active smokers
Outcome results
None listed