The Effects of Orchiectomy and Age on Vascular and Metabolic Health in Older Versus Younger Transgender Women

Last updated: September 13, 2024
Sponsor: University of Colorado, Denver
Overall Status: Completed

Phase

N/A

Condition

Inflammation

Diabetes And Hypertension

Hypertriglyceridemia

Treatment

No intervention

Clinical Study ID

NCT05195164
20-2141
NIH 5 K12 HD057022
  • Ages 18-99
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Total Participants: 17
Treatment Group(s): 1
Primary Treatment: No intervention
Phase:
Study Start date:
March 22, 2021
Estimated Completion Date:
December 31, 2023

Study 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 before and after orchiectomy. Trans women appear to be at greater risk for cardiovascular disease (CVD) and blood clots compared to non-trans adults. The effect of orchiectomy on CVD risk among trans women is unknown, but orchiectomy may change blood vessel function and metabolic health. The investigators will examine blood vessel function and metabolic profiles of trans women before and at several timepoints after orchiectomy to identify age-related differences in CVD risk factors. This knowledge may lead to new approaches to prevent CVD in trans women as well as all people regardless of gender identity.

Connect with a study center

  • University of Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

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