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Cardiomodulatory Effects of Gender-Affirming Hormone Therapy

NCT07128771 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 450

Last updated 2026-01-12

No results posted yet for this study

Summary

Gender-affirming hormone therapy is today a well-established treatment for individuals experiencing gender-incongruence. However, little is known about the long-term effects of gender-affirming hormone therapy on the cardiovascular system and it is unknown whether gender-affirming hormone therapy is associated with negative, neutral or perhaps positive effects on cardiovascular risk factors. The aim of the study The Cardiomodulatory Effects of Gender-Affirming Hormone Therapy (CARMEN) is therefore to contribute to fill this important knowledge gap by a longitudinal assessment of the affect of gender-affirming hormone therapy with a detailed characterization using state of the art methods for cardiovascular imaging, circulating biomarker assessment, body composition, and self-reported health-related quality of life. The information obtained will inform both candidates for gender-affirming hormone therapy, their families, health personnel and health policy decision makers about the cardiometabolic effects and cardiovascular risks of such therapy and will be relevant information in shared decision-making processes.

Conditions

Sponsors & Collaborators

  • Oslo University Hospital

    collaborator OTHER

  • University of Oslo

    collaborator OTHER

  • University Hospital, Akershus

    lead OTHER

Principal Investigators

  • Torbjørn Omland, MD, PhD, MPH · University of Oslo

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-05
Primary Completion
2027-08-31
Completion
2030-10-31

Countries

  • Norway

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07128771 on ClinicalTrials.gov