drugset / Trial / NCT04922424

Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men

NCT04922424

Phase 1 Withdrawn Yale University
RandomizedCrossoverTriple-blindOther

Summary

Gender-identity differences are becoming increasingly diagnosed in the US and treatment with gender-affirming hormone therapy (GAHT) is associated with improved mental health outcomes. However, GAHT has been associated with cardiovascular risk in adult transgender patients, although mechanisms and treatments have not been explored. Understanding the cardiovascular effects and exploring the potential of a lipid sensitive statin as a potential treatment is important to optimizing safe treatment strategies for transgender men in mitigating this modifiable risk factor, and designing and implementing effective interventions.

Timeline

Start
2022-09-30
Primary completion
2023-08-31
Completion
2023-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Atorvastatin Small molecule 20 mg