NCT05387577

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Dec 2021

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 7, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 24, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2022

Completed
Last Updated

December 21, 2022

Status Verified

December 1, 2022

Enrollment Period

12 months

First QC Date

April 16, 2022

Last Update Submit

December 19, 2022

Conditions

TransgenderismClotting Disorder

Keywords

EstradiolEstrogensHormonesHormones, Hormone Substitutes, Hormone AntagonistsPhysiological Effects of DrugsTransgender

Outcome Measures

Primary Outcomes (1)

  • Coagulation system activation and fibrinolysis due to estradiol administration

    Comparison of morning fasting labs (fibrinogen, von-Willebrand Factor (vWF) ristocetin cofactor, vWF antigen, D-dimer, protein C activity, free protein S activity, Factors VII, VIII, IX, thrombin generation, plasminogen activator inhibitor (PAI-1), tissue-type plasminogen activator (t-PA) and t-PA activity) in transgender women taking estradiol via different routes of administration. Our hypothesis is that transdermal estradiol will result in less coagulation system activation and no effect on PAI-1 or t-PA. Oral estradiol will result in the most coagulation system activation and will effect PAI-1 and t-PA: Oral estradiol \> sublingual estradiol \> transdermal estradiol.

    8 months

Secondary Outcomes (1)

  • Thrombotic risk due to estradiol administration

    8 months

Study Arms (3)

Sublingual Estradiol

ACTIVE COMPARATOR

Sublingual estradiol administered for 8 weeks

Drug: Estradiol Tablets

Oral Estradiol

ACTIVE COMPARATOR

Oral estradiol administered for 8 weeks

Drug: Estradiol Tablets

Transdermal Estradiol

ACTIVE COMPARATOR

Transdermal estradiol administered for 8 weeks

Drug: Transdermal patch

Interventions

Estradiol TabletsDRUG

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

Also known as: Sublingual estradiol tablets
Sublingual Estradiol
Transdermal patchDRUG

Estradiol patch therapy for 8 weeks

Also known as: Transdermal estradiol patch
Transdermal Estradiol

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsTranswoman (gender identity female, assigned male at birth)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Gender identity of male to female or transwoman

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

TranssexualismHemostatic Disorders

Interventions

EstradiolTransdermal Patch

Condition Hierarchy (Ancestors)

SexualitySexual BehaviorBehaviorVascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsEquipment and Supplies

Study Officials

  • Jenna Sarvaideo, DO

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 16, 2022

First Posted

May 24, 2022

Study Start

December 7, 2021

Primary Completion

November 23, 2022

Study Completion

November 23, 2022

Last Updated

December 21, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will share

All individual participant data that underlie results in a publication.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
starting 3 months after publication
Access Criteria
IPD will be shared if PI is directly contacted and asked for the above information.

Locations

US(1)