Cardiovascular effects of gender-affirming hormones in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational cohort at a tertiary center in Bologna following transgender adults receiving either masculinizing (testosterone) or feminizing (estradiol plus androgen-lowering agents) gender-affirming hormone therapy. Participants are adults with a diagnosis of gender incongruence who have been on continuous hormone therapy for at least 12 months and who have no prior cardiovascular events. The study collects clinical data and cardiovascular risk markers over time to characterize changes in cardiovascular health associated with GAHT. All participation requires informed consent and follow-up visits at the coordinating center.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* Any hormone therapy received before recruitment
* History of cardiovascular events prior to the initiation of hormone therapy

Where it's running

• IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
  Bologna, Bo, Italy Recruiting

Study contacts

• Study coordinator: Maria Cristina Meriggiola, MD, PhD
• Email: cristina.meriggiola@unibo.it
• Phone: +390512144394

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.