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Completed

NCT Number: NCT05010707

Transgender Estradiol Affirming Therapy

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.

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Key information

Conditions

Transgenderism Behavior Sexual Behavior Sexuality Transsexualism

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Washington University Transgender Center

St Louis, Missouri, 63112, United States

About this study

Transgender patients suffer from poor mental and medical health outcomes compared to their cisgender peers. Given the widespread acknowledgment of the health care needs of transgender people, priority should be given to those actions that will ensure safe and appropriate care in health centers.

The current hormone therapy is not uniform and depends on the health care system, cost considerations, and differences in the regional availability of estrogens and antiandrogens. A typical regimen includes estrogen to provide feminizing effects in conjunction with therapy to block testosterone (antiandrogens or gonadotropin-releasing hormone [GnRH] analogs). Estrogen also inhibits testosterone secretion.

Ethinyl estradiol was previously the mainstay of most estrogen-directed therapies; this is no longer the case due to its increased risk of cardiovascular death and increased incidence of deep venous thrombosis. 17-beta estradiol, which can be provided in tablet, patch, and injection, is currently the preferred formulation.

This open label, pilot, randomized clinical trial will evaluate the effectiveness and safety of gender affirming hormone therapy with estrogen and the degree of testosterone suppression achieved in transgender female patients when placed on daily sublingual 17-beta estradiol, twice daily sublingual 17-beta estradiol, or transdermal 17-beta estradiol. All patients will also receive spironolactone as antiandrogen.

One of the major complications from estradiol GAHT is thromboembolism. The investigators will also determine the effects of the different estradiol regimens on thrombosis markers. These studies will be the first to determine if the dosing regimen of estradiol affects risk markers in transgender women.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female transgender patients between the ages of 18 to 30 years of age who are seen at the Washington University Transgender Center. Patients must have met the eligibility and readiness criteria for gender-affirming hormone therapy.

Exclusion criteria

  • GnRH agonist for the last 12 months
  • History of liver disease
  • Dyslipidemia requiring treatment
  • Cigarette smoking
  • Body mass index >30 kg/m2

Treatment and study plan

Transdermal patch

Drug

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

Other names: Daily

Pro-thrombotic markers

Diagnostic Test

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.

Metabolic markers

Diagnostic Test

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.

Hormone Profile

Diagnostic Test

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.

Daily Sublingual Tablet

Drug

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

Other names: Once daily dosing

BID Sublingual Tablet

Drug

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

Other names: Twice daily dosing

Spironolactone

Drug

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

Other names: Daily

Primary outcomes

  1. Total Testosterone Level in Transgender Female Patients

    Time frame: Change from baseline total testosterone level at 1 and 6 months

    Degree of testosterone suppression by measuring total testosterone level in transgender female patients undergoing hormonal affirming therapy, clinical testosterone level in pg/mL

  2. Estradiol Level in Transgender Female Patients

    Time frame: Change from baseline estradiol level at 1 and 6 months

    Degree of testosterone suppression by measuring estradiol level in transgender female patients affirming hormone therapy

  3. Estrone Level in Transgender Female Patients

    Time frame: Change from baseline estrone level at 1, and 6 months

    Degree of testosterone suppression by measuring estrone level in transgender female patients affirming hormone therapy

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Effectiveness and Safety of Different Estradiol Replacement Therapies in Transgender Female

Acronym: TREAT

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Aug 18, 2021
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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