drugset / Trial / NCT05387577

Coagulation and Fibrinolysis of Estradiol in Transwomen

NCT05387577

Phase 0 Terminated 6 enrolled Medical College of Wisconsin
Non-randomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2021-12-07
Primary completion
2022-11-23
Completion
2022-11-23

Drugs

EvaluationDrugModalityDoseRoute
Comparator Estradiol Other / unclassified 1 mg Other