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Effects of Aging and Gender-Affirming Hormone Therapy on Vascular Endothelial Function and Metabolic Profiles in Transgender Women

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status

Completed

Conditions

Appetitive Behavior
Gender Identity
Lipid Disorder
Transgender
Vascular Stiffness
Blood Pressure
Insulin Sensitivity
Vascular Inflammation

Treatments

Other: No intervention

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT04066283
18-2258

Details and patient eligibility

About

This study will examine markers of vascular endothelial function (vascular health) and metabolic profiles in younger versus older transgender women (people who were assigned male at birth but whose gender identity is female). Data will also be compared to those from cisgender women and men.

Enrollment

29 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Aged 18-40 years old or 50-75 years old
  • Identify as a transgender woman
  • Have taken estradiol and spironolactone for at least one year
  • Currently taking oral or transdermal estradiol

Exclusion criteria

  • 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
  • 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

Trial design

29 participants in 2 patient groups

Older transgender women
Description:
This cohort will consist of transgender women aged 50-75 years old who have taken estradiol and spironolactone for at least one year.
Treatment:
Other: No intervention
Younger transgender women
Description:
This cohort will consist of transgender women aged 18-40 years old who have taken estradiol and spironolactone for at least one year.
Treatment:
Other: No intervention

Trial contacts and locations

1

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Central trial contact

Sean Iwamoto, MD; Amanuail Gebregzabheir

Data sourced from clinicaltrials.gov

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