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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Page 1 of 1 (1 locations)

1

Froedtert Hospital

Milwaukee, Wisconsin, United States, 53226