Coagulation and Fibrinolysis of Estradiol in Transwomen

• Status: Recruiting
• Trial end date: 2022-12-07
• Target enrollment: 0
• Participant gender: Male

Summary

The specific aim for our study is to measure coagulation system activation and fibrinolysis following transdermal versus sublingual versus oral estradiol versus in transgender women.

Hypothesis: Transdermal estradiol will result in less coagulation system activation and no effect on plasminogen activator inhibitor (PAI-1) or tissue-type plasminogen activator (t-PA). Oral estradiol will result in the most coagulation system activation and effect on PAI-1 and t-PA: Oral estradiol > sublingual estradiol > transdermal estradiol.

A prospective crossover study will include ten subjects given estradiol 1 mg daily and instructed to take it orally, sublingually, or transdermal for 2 months with a 2-week washout period between routes of administration. Labs will be measured 7 times during the study.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medical College of Wisconsin
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• 18 years or older

• Gender identity of male to female or transwoman

Exclusion Criteria:

• Liver disease

• History of blood clot

• Bleeding disorder

• Active or recent (e.g., within the past year) stroke

• Myocardial infarction,

• History of orchiectomy

• History of breast cancer,

• Known sensitivity or allergy to any components of the medications used

• Currently taking a potent CYP3A4 inhibitor or inducer.