Transgender Estradiol Affirming Therapy

PHASE2CompletedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

August 2, 2021

Primary Completion Date

August 1, 2023

Study Completion Date

January 1, 2024

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.

Trial Locations (1)

63112

Washington University Transgender Center, St Louis

All Listed Sponsors
lead

Washington University School of Medicine

OTHER

NCT05010707 - Transgender Estradiol Affirming Therapy | Biotech Hunter | Biotech Hunter