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

NCT04922424 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2022-11-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Atorvastatin

Subjects will ingest placebo or ingest 20 mg atorvastatin for 30 days first. We will include 30 days of washout between treatments to minimize any potential carryover effects.

OTHER

placebo

Subjects will ingest placebo or ingest 20 mg atorvastatin for 30 days first. We will include 30 days of washout between treatments to minimize any potential

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Nina Stachenfeld · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-30
Primary Completion
2023-08-31
Completion
2023-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT04922424 on ClinicalTrials.gov