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

MaineHealth

Status and phase: Terminated; Phase 4

Conditions: Gender Dysphoria

Treatments: Drug: 17beta Estradiol

Study type: Interventional

Funder types: Other

Identifiers

NCT05428215

1737257

Details and patient eligibility

About

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

Enrollment: 2 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

2 participants in 2 patient groups

PO then SL

Active Comparator group

Description:

Subjects will administer 17-beta-estradiol orally (PO) for Study Day 1-14, followed by administration of 17-beta-estradiol sublingually (SL) for Study Day 15-28.

Treatment:

Drug: 17beta Estradiol

SL then PO

Active Comparator group

Description:

Subjects will administer 17-beta-estradiol sublingually (SL) for Study Day 1-14, followed by administration of 17-beta-estradiol orally (PO) for Study Day 15-28.

Treatment:

Drug: 17beta Estradiol