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

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: MaineHealth
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Polyestradiol phosphate

Criteria

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