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

NCT05428215 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2023-07-27

No results posted yet for this study

Summary

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

Conditions

  • Gender Dysphoria

Interventions

DRUG

17beta Estradiol

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

Sponsors & Collaborators

  • MaineHealth

    lead OTHER

Principal Investigators

  • Katherine Davis, MD · MaineHealth

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-29
Primary Completion
2023-07-20
Completion
2023-07-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05428215 on ClinicalTrials.gov