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

Phase 4TerminatedNCT05428215

MaineHealth2 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Gender Dysphoria

Interventions

17beta EstradiolDRUG

Subjects will take individualized therapeutic dose of 17-beta-estradiol via sublingual and oral administration

Eligibility

Sex: MALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Maine Medical Center

Portland, Maine, United States

Outcomes

Primary Outcomes

Estradiol absorption

Mean area under the curve of estradiol

Time frame: Over 24 hours

Secondary Outcomes

Peak serum estradiol

With subjects as own controls, compare peak E2 with sublingual vs oral administration

Time frame: Peak over 24 hour period

Serum estradiol Nadir

Baseline serum estradiol level after 2 weeks of oral administration versus sublingual administration at same dose

Time frame: 24 hours from last estradiol administration

Suppression of Testosterone

Testosterone level after 2 weeks of estradiol administration via oral and sublingual method, respectively

Time frame: 24 hours from last estradiol administration on Study Day 14 and 28

Serum estrone to estradiol ratio

E1:E2 ratio over 24 hour period with sublingual vs oral administration

Time frame: Hours from administration of estradiol: 0, 1, 2, 4, 6, and 8 hours

Sex hormone binding globulin

SHBG after 2 weeks of estradiol sublingual vs oral administration

Time frame: 0 hours from estradiol administration on Study Day 14 and 28

Data from ClinicalTrials.gov

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