Status:
RECRUITING
Cardiovascular Health of Transgender Individuals During the Gender-affirming Pathway
Lead Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Conditions:
Gender Incongruence
Cardiovascular (CV) Risk
Eligibility:
All Genders
18+ years
Brief Summary
Gender incongruence, now classified in ICD-11 as a "marked and persistent incongruence between an individual's experienced gender and the gender assigned at birth," is managed in dedicated, multidisci...
Detailed Description
Gender incongruence, described in the eleventh revision of the International Classification of Diseases (ICD-11) as "a marked and persistent incongruence between an individual's experienced gender and...
Eligibility Criteria
Inclusion
- Diagnosis of gender incongruence
- Age 18 years or older at the start of therapy
- Undergoing gender-affirming (replacement or suppressive) hormone therapy with testosterone or with estradiol plus anti-androgens for at least 12 months
- Provision of informed consent for study participation and for the processing of personal and sensitive data
Exclusion
- Any hormone therapy received before recruitment
- History of cardiovascular events prior to the initiation of hormone therapy
Key Trial Info
Start Date :
July 18 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2035
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT07187947
Start Date
July 18 2025
End Date
December 31 2035
Last Update
September 23 2025
Active Locations (1)
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1
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, BO, Italy, 40138