Transgender Estradiol Affirming Therapy

Summary

The purpose of this open label, pilot, randomized clinical trial is to evaluate the effectiveness, safety and tolerability of estrogen use in transgender female and the degree of testosterone suppression achieved in this population when placed on gender affirming pharmacological therapy.

Conditions

• Transgenderism

Interventions

DRUG

Transdermal patch

Participants will be prescribed the medication and dosed based on their hormonal profile. Goal is achieve estradiol level between 100-200 pg/mL and to suppress testosterone to cisgender female levels

DIAGNOSTIC_TEST

Pro-thrombotic markers

Once participants are started on gender affirming hormone therapy, pro-thombotic markers will be checked at baseline and every 6 months. Pro-thrombotic markers will include: Factor II, Factor IX, Factor XI, Von Willebrand factor, Protein C, Protein S, activated Protein C resistance.

DIAGNOSTIC_TEST

Metabolic markers

Once participants are started on gender affirming hormone therapy, metabolic markers will be checked at baseline and every 6 months. Markers will include: Insulin level, fasting glucose, body mass index, waist circumference.

DIAGNOSTIC_TEST

Hormone Profile

Once participants are started on gender affirming hormone therapy, hormonal levels will be checked every 4 weeks until estradiol and testosterone levels are within goal as established by standard of care.

DRUG

Daily Sublingual Tablet

Participants will be prescribed the medication and dosed based on their hormonal profile. Participants will take dose as once daily medication. Goal is achieve estradiol level between 100-200 pg/mL and to suppress testosterone to cisgender female levels

DRUG

BID Sublingual Tablet

Participants will be prescribed the medication and dosed based on their hormonal profile. Participants will take dose as twice daily medication. Goal is achieve estradiol level between 100-200 pg/mL and to suppress testosterone to cisgender female levels

DRUG

Spironolactone

All patients will also receive spironolactone. Spironolactone will be started at 50 mg daily and will increase to standard dose.

Sponsors & Collaborators

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• Ginger Nicol, MD · Washington University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

30 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-08-02

Primary Completion

2023-08-01

Completion

2024-01-01

FDA Drug

Yes

Countries

• United States

Study Locations