Status:
TERMINATED
Comparison of PKs of 17-Beta-Estradiol Via Sublingual Placement Versus Swallowing in Male-to-Female Transgender Patients
Lead Sponsor:
MaineHealth
Conditions:
Gender Dysphoria
Eligibility:
MALE
18+ years
Phase:
PHASE4
Brief Summary
This crossover study will investigate the pharmacokinetics of oral versus sublingual administration of 17-beta-estradiol in the trans-female population.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2023
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT05428215
Start Date
December 29 2022
End Date
July 20 2023
Last Update
July 27 2023
Active Locations (1)
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1
Maine Medical Center
Portland, Maine, United States, 04102