Comparison of PKs of 17-Beta-Estradiol Via Sublingual Placement Versus Swallowing in Male-to-Female Transgender Patients
NCT ID: NCT05428215
Last Updated: 2023-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
2 participants
INTERVENTIONAL
2022-12-29
2023-07-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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PO then SL
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.
17beta Estradiol
Subjects will take individualized therapeutic dose of 17-beta-estradiol via sublingual and oral administration
SL then PO
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.
17beta Estradiol
Subjects will take individualized therapeutic dose of 17-beta-estradiol via sublingual and oral administration
Interventions
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17beta Estradiol
Subjects will take individualized therapeutic dose of 17-beta-estradiol via sublingual and oral administration
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
MALE
Yes
Sponsors
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MaineHealth
OTHER
Responsible Party
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Katherine Davis
Physician- MH Obstetrics and Gynecology
Principal Investigators
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Katherine Davis, MD
Role: PRINCIPAL_INVESTIGATOR
MaineHealth
Locations
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Maine Medical Center
Portland, Maine, United States
Countries
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Other Identifiers
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1737257
Identifier Type: -
Identifier Source: org_study_id
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