NCT05169762

Brief Summary

Cohort study in 100 transgender women treated with gender affirming hormone treatment. Follow up affter 1year, 3 years, 5 years and 10 years, Outcomes regarding cardiovascular effects of hormone treatment.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
113mo left

Started Feb 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress31%
Feb 2022Sep 2035

First Submitted

Initial submission to the registry

September 19, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 27, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
13.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2035

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2035

Last Updated

March 21, 2025

Status Verified

March 1, 2025

Enrollment Period

13.6 years

First QC Date

September 19, 2021

Last Update Submit

March 18, 2025

Conditions

Transgenderism

Keywords

gender affirming hormone treatmentestrogencardiovascular risk

Outcome Measures

Primary Outcomes (1)

  • coronary plaque formation

    mm3

    1 year

Study Arms (1)

transgender women

transgender women eligeble to start gender affirming hormone treatment

Other: standard treatment

Interventions

standard treatmentOTHER

starndard treatment for transgender women

transgender women

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsassigned male at birth, identifiing as transgender women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

transgender women

You may qualify if:

  • assigned male at birth and eligeble for gender affirming feminizing treatment

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OdenseUH

Odense, 5230, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Transsexualism

Condition Hierarchy (Ancestors)

SexualitySexual BehaviorBehavior

Study Officials

  • Dorte Glintborg

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dorte Glintborg

CONTACT

+4565411807dorte.glintborg@rsyd.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

September 19, 2021

First Posted

December 27, 2021

Study Start

February 1, 2022

Primary Completion (Estimated)

September 1, 2035

Study Completion (Estimated)

September 1, 2035

Last Updated

March 21, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)