Comparison of PKs of 17-Beta-Estradiol Via Sublingual Placement Versus Swallowing in Male-to-Female Transgender Patients

Comparison of Pharmacokinetics of 17-Beta-Estradiol Via Oral Administration With Sublingual Placement Versus Oral Administration With Swallowing of 17-Beta-estradiol in Male-to-Female Transgender Patients

This crossover study will investigate the pharmacokinetics of oral versus sublingual administration of 17-beta-estradiol in the trans-female population.

Inclusion Criteria:

• English speaker
• Currently taking 17-beta-estradiol tablet daily via sublingual or oral route on dose therapeutic for gender-affirming therapy; steady dose for at least 4 weeks
• Serum estradiol and testosterone levels within target therapeutic range (75-200 pg/mL and <55 ng/dL, respectively)

Exclusion Criteria:

• Active or history of deep venous thrombosis/pulmonary embolism
• Active or recent (within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction)
• Liver dysfunction
• History of breast cancer
• History of orchiectomy
• Known sensitivity or allergy to any components of the study medication
• Taking potent CYP3A4 inhibitors or inducers