Phase 2
N=39
Transgender Estradiol Affirming Therapy
Transgenderism
Bottom Line
View on ClinicalTrials.gov: NCT05010707 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Total Testosterone Level in Transgender Female Patients — 498.6; 481.3; 505.3; 62.7 pg/mL — p=0.005
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Transdermal patch (Drug); Pro-thrombotic markers (Diagnostic_test); Metabolic markers (Diagnostic_test); Hormone Profile (Diagnostic_test); Daily Sublingual Tablet (Drug); BID Sublingual Tablet (Drug); Spironolactone (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Washington University School of Medicine
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Testosterone Level in Transgender Female Patients |
498.6; 481.3; 505.3; 62.7; 278.5; 313.8 | 0.005 sig |
| PRIMARY Estradiol Level in Transgender Female Patients |
28.3; 25.8; 23.4; 56.8; 52.6; 55.2 | 0.951 |
| PRIMARY Estrone Level in Transgender Female Patients |
33.5; 27.7; 26.7; 41.0; 302; 240.1 | 0.004 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT05010707). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.