Status:
COMPLETED
Transgender Estradiol
Lead Sponsor:
Medical College of Wisconsin
Conditions:
Transgender Persons
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
Blogs, word-of-mouth, and small studies from the 1990s in the premature ovarian insufficiency and menopause populations have suggested sublingual or transdermal estradiol may be safer and/or more effe...
Detailed Description
Patient will plan on being in the Adult Translational Research Unit (A-TRU) for 8 hours. They will be assigned to a suite. They will get 7 blood draws at hours 0,1,2,3,4,6,8 and vitals at the beginnin...
Eligibility Criteria
Inclusion
- Transgender male-to-female
- Naive to hormone therapy
- English speaker
- 18 years of age or older
Exclusion
- History of hormone replacement therapy
- Orchiectomy
- Needle phobia
- Serious bleeding condition
- Active deep vein thrombosis, pulmonary embolism or history of these conditions
- Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction)
- Liver dysfunction or disease
- History of breast cancer
- Known sensitivity or allergy to any components of the medications used
- Taking potent CYP3A4 inhibitors or inducers, as determined by team pharmacist
- Taking a medication that may cause additional physical or mental harm if stopped
Key Trial Info
Start Date :
September 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 13 2020
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04036500
Start Date
September 23 2019
End Date
July 13 2020
Last Update
April 11 2025
Active Locations (1)
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1
Froedtert Hospital
Milwaukee, Wisconsin, United States, 53226