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Coagulation and Fibrinolysis of Estradiol in Transwomen

NCT05387577 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2022-12-21

No results posted yet for this study

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.

Conditions

  • Transgenderism
  • Clotting Disorder

Interventions

DRUG

Estradiol Tablets

Oral estradiol will be taken sublingually, 1 mg BID for 8 weeks

DRUG

Transdermal patch

Estradiol patch therapy for 8 weeks

DRUG

Estradiol Tablets

Oral estradiol 1 mg BID for 8 weeks

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Jenna Sarvaideo, DO · Medical College of Wisconsin

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-07
Primary Completion
2022-11-23
Completion
2022-11-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05387577 on ClinicalTrials.gov