Status:
COMPLETED
The Effects of Orchiectomy and Age on Vascular and Metabolic Health in Older Versus Younger Transgender Women
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Center for Advancing Translational Sciences (NCATS)
Conditions:
Transgender
Gender Identity
Eligibility:
All Genders
18-99 years
Brief Summary
This study plans to learn more about differences in heart disease risk after gender-affirming orchiectomy (i.e., testes removal) in older transgender (trans) women compared to younger trans women.
Detailed Description
The global aim of this study is to characterize cardiometabolic risk (measured by vascular, metabolic and biochemical factors-which have not been extensively studied prospectively) in trans women befo...
Eligibility Criteria
Inclusion
- Aged 18 years and older
- Identify as a transgender woman
- Have taken estradiol and spironolactone for at least one year
- Currently taking oral or transdermal or injectable estradiol
- Have not yet undergone but desire orchiectomy
Exclusion
- Under 18 years of age
- Don't identify as a transgender woman
- Not currently taking estradiol or spironolactone
- Have been on estradiol and spironolactone for less than one year
- History of orchiectomy
- Not deemed a candidate for orchiectomy
- Current tobacco smoker
- Current illicit drug use
- History of prior or active estrogen-dependent neoplasms
- Acute liver or gallbladder disease
- Venous thromboembolism
- Hypertriglyceridemia \>500 mg/dL
- Fasted plasma glucose \>7.0 mmol/L or previously treated diabetes
- Resting blood pressure \>140/90 mmHg
Key Trial Info
Start Date :
March 22 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT05195164
Start Date
March 22 2021
End Date
December 31 2023
Last Update
September 19 2024
Active Locations (1)
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1
University of Colorado
Aurora, Colorado, United States, 80045