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Coagulation and Fibrinolysis of Estradiol in Transwomen

NCT ID: NCT05387577

Last Updated: 2022-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-07

Study Completion Date

2022-11-23

Brief Summary

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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.

Detailed Description

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Subjects will report to our Adult Translational Research Unit for labs at baseline (2 weeks after HRT washout if needed). Both fibrinolysis and testosterone labs have a diurnal variation. Therefore, fasting labs will be drawn at approximately 8 AM. Five subjects will start oral estradiol and 5 will start sublingual estradiol for 8 weeks. Froedtert's Pharmacy Investigational Drug Service will provide the study estradiol. There will be a 2-week washout period between treatment periods. Fasting labs will be drawn at approximately 8 AM prior to Treatment Period 2. The groups will switch therapy. Those that took oral estradiol during Treatment Period 1 will take sublingual estradiol for 8 weeks. Those that took sublingual estradiol during Treatment Period 1 will take oral estradiol for 8 weeks. Finally, all subjects will start the transdermal for 8 weeks for Treatment Period 3. Final set of labs will be drawn at approximately 8 AM 2 weeks after Treatment Period 3. The investigators will call subjects every 2 weeks to assess their adherence to the treatment protocol and remind them of the importance of allowing the tablet to dissolve when taking estradiol sublingually.

Conditions

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Transgenderism Clotting Disorder

Keywords

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Estradiol Estrogens Hormones Hormones, Hormone Substitutes, Hormone Antagonists Physiological Effects of Drugs Transgender

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sublingual Estradiol

Sublingual estradiol administered for 8 weeks

Group Type ACTIVE_COMPARATOR

Estradiol Tablets

Intervention Type DRUG

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

Oral Estradiol

Oral estradiol administered for 8 weeks

Group Type ACTIVE_COMPARATOR

Estradiol Tablets

Intervention Type DRUG

Oral estradiol 1 mg BID for 8 weeks

Transdermal Estradiol

Transdermal estradiol administered for 8 weeks

Group Type ACTIVE_COMPARATOR

Transdermal patch

Intervention Type DRUG

Estradiol patch therapy for 8 weeks

Interventions

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Estradiol Tablets

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

Intervention Type DRUG

Transdermal patch

Estradiol patch therapy for 8 weeks

Intervention Type DRUG

Estradiol Tablets

Oral estradiol 1 mg BID for 8 weeks

Intervention Type DRUG

Other Intervention Names

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Sublingual estradiol tablets Transdermal estradiol patch Oral Estradiol tablets

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Medical College of Wisconsin

OTHER

Sponsor Role lead

Responsible Party

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Jenna Sarvaideo

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jenna Sarvaideo, DO

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

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Froedtert Hospital

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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PRO00036346

Identifier Type: -

Identifier Source: org_study_id