NCT05195164

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 22, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 18, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2.8 years

First QC Date

October 22, 2021

Last Update Submit

September 13, 2024

Conditions

TransgenderGender IdentityVascular StiffnessVascular InflammationInsulin SensitivityBlood PressureLipid DisorderAppetitive Behavior

Outcome Measures

Primary Outcomes (4)

  • Evaluation of endothelial function (flow-mediated dilation (FMD) at Baseline

    Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.

    Baseline

  • Evaluation of endothelial function (flow-mediated dilation (FMD) at 1 Month

    Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.

    1 month

  • Evaluation of endothelial function (flow-mediated dilation (FMD) at 6 Months

    Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.

    6 month

  • Evaluation of endothelial function (flow-mediated dilation (FMD) at 12 Months

    Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.

    12 month

Secondary Outcomes (27)

  • Evaluation of carotid artery compliance

    Baseline, 1 mo., 6 mo., 12 mo.

  • Evaluation of carotid artery beta stiffness index

    Baseline, 1 mo., 6 mo., 12 mo.

  • Carotid artery intimal-medial thickness

    Baseline, 1 mo., 6 mo., 12 mo.

  • Evaluation of oxidant burden: oxidized LDL

    Baseline, 1 mo., 6 mo., 12 mo.

  • Evaluation of oxidant burden: nitrotyrosine

    Baseline, 1 mo., 6 mo., 12 mo.

  • +22 more secondary outcomes

Study Arms (2)

Older transgender women

This cohort will consist of healthy transgender women aged 45 and above who have not undergone but desire orchiectomy, who have been on estrogen (history of oral, transdermal or injectable) and spironolactone for at least one year.

Other: No intervention

Younger transgender women

This cohort will consist of healthy transgender women aged 18-44 who have not undergone but desire orchiectomy, who have been on estrogen (history of oral, transdermal or injectable) and spironolactone for at least one year.

Other: No intervention

Interventions

No interventionOTHER

There was no intervention

Older transgender womenYounger transgender women

Eligibility Criteria

Age18 Years - 99 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsTransgender women (people who were assigned male at birth but whose gender identity is female). They may or may not have legally changed their gender marker.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Transgender women from the Denver metropolitan area and/or who utilize health care at University of Colorado Hospital.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and endothelial cells

MeSH Terms

Conditions

Insulin ResistanceLipid Metabolism DisordersAppetitive Behavior

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehavior, AnimalBehavior

Study Officials

  • Sean Iwamoto, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2021

First Posted

January 18, 2022

Study Start

March 22, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)