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

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

Phase

N/A

Condition

Inflammation

Hormone Deficiencies

Diabetes And Hypertension

Treatment

No intervention

Clinical Study ID

NCT04066283
18-2258
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 29
Treatment Group(s): 1
Primary Treatment: No intervention
Phase:
Study Start date:
April 17, 2019
Estimated Completion Date:
December 31, 2023

Connect with a study center

  • University of Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

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