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

Gender Dysphoria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05428215
• Other study ID #: 1737257
• Status: Terminated
• Phase: Phase 4
• Start date: December 29, 2022
• Est. completion date: July 20, 2023

Study information

• Verified date: July 2023
• Source: MaineHealth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 20, 2023
• Est. primary completion date: July 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gender Dysphoria

Intervention

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

Locations

Country	Name	City	State
United States	Maine Medical Center	Portland	Maine

Sponsors (1)

Lead Sponsor	Collaborator
MaineHealth

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estradiol absorption	Mean area under the curve of estradiol	Over 24 hours
Secondary	Peak serum estradiol	With subjects as own controls, compare peak E2 with sublingual vs oral administration	Peak over 24 hour period
Secondary	Serum estradiol Nadir	Baseline serum estradiol level after 2 weeks of oral administration versus sublingual administration at same dose	24 hours from last estradiol administration
Secondary	Suppression of Testosterone	Testosterone level after 2 weeks of estradiol administration via oral and sublingual method, respectively	24 hours from last estradiol administration on Study Day 14 and 28
Secondary	Serum estrone to estradiol ratio	E1:E2 ratio over 24 hour period with sublingual vs oral administration	Hours from administration of estradiol: 0, 1, 2, 4, 6, and 8 hours
Secondary	Sex hormone binding globulin	SHBG after 2 weeks of estradiol sublingual vs oral administration	0 hours from estradiol administration on Study Day 14 and 28