Clinical trial NCT05010707: Transgender Estradiol Affirming Therapy
Official title: Effectiveness and Safety of Different Estradiol Replacement Therapies in Transgender Female
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Transgenderism
Keywords: Transgender female
Gender affirming hormone therapy
Estrogen therapy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 39
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants who agreed to be in the study will undergo block randomization into three groups:

1. daily sublingual 17 beta estradiol
2. twice daily sublingual 17 beta estradiol
3. transdermal 17 beta estradiol

All patients will also receive spironolactone as antiandrogen.
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Total Testosterone Level in Transgender Female Patients
timeFrame: Change from baseline total testosterone level at 1 and 6 months
measure: Estradiol Level in Transgender Female Patients
timeFrame: Change from baseline estradiol level at 1 and 6 months
measure: Estrone Level in Transgender Female Patients
timeFrame: Change from baseline estrone level at 1, and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University Transgender Center
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Ginger Nicol, MD
role: PRINCIPAL_INVESTIGATOR
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