Oral Estradiol for Transgenderism

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Froedtert Hospital, Milwaukee, WI
Transgenderism+3 More
Estradiol Tablets - Drug
Eligibility
18+
Male
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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.

Eligible Conditions

  • Transgenderism
  • Coagulation Disorder

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 8 months

8 months
Coagulation system activation and fibrinolysis due to estradiol administration
Medication satisfaction questionnaire will be completed
Thrombotic risk due to estradiol administration

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Oral Estradiol
1 of 3
Transdermal Estradiol
1 of 3
Sublingual Estradiol
1 of 3
Active Control

10 Total Participants · 3 Treatment Groups

Primary Treatment: Oral Estradiol · No Placebo Group · Phase < 1

Oral Estradiol
Drug
ActiveComparator Group · 1 Intervention: Estradiol Tablets · Intervention Types: Drug
Transdermal Estradiol
Drug
ActiveComparator Group · 1 Intervention: Transdermal patch · Intervention Types: Drug
Sublingual Estradiol
Drug
ActiveComparator Group · 1 Intervention: Estradiol Tablets · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 8 months
Closest Location: Froedtert Hospital · Milwaukee, WI
Photo of Milwaukee 1Photo of Milwaukee 2Photo of Milwaukee 3
2010First Recorded Clinical Trial
1 TrialsResearching Transgenderism
36 CompletedClinical Trials

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
545 Previous Clinical Trials
1,150,375 Total Patients Enrolled
1 Trials studying Transgenderism
90 Patients Enrolled for Transgenderism
Jenna Sarvaideo, DOPrincipal InvestigatorMedical College of Wisconsin

Eligibility Criteria

Age 18+ · Male Participants · 2 Total Inclusion Criteria

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You must be at least 18 years old.\n

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.