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Behavioural Intervention

Gender-Affirming Treatments for Lung Health

N/A

Recruiting

Led By Gustavo Cortes Puentes, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6-month follow-up, 12-month follow-up, 18-month follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial studies if gender affirming care affects lung health.

Who is the study for?

This trial is for transgender and gender diverse patients at the Mayo Clinic who are starting hormonal gender-affirming therapies. They must be able to perform lung function tests and give informed consent, or have a guardian's consent if under 18. People with recent heart issues, chronic lung diseases, or those unable to consent are excluded.

What is being tested?

The study is testing how gender-affirming hormone treatments affect lung function in transgender and gender diverse individuals. It involves performing spirometry and plethysmography—tests that measure how well the lungs work.

What are the potential side effects?

While not directly related to side effects of medications, spirometry and plethysmography can cause temporary discomfort like dizziness or shortness of breath due to the deep breathing required during the tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6-month follow-up, 12-month follow-up, 18-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6-month follow-up, 12-month follow-up, 18-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6-month follow-up, 12-month follow-up, 18-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in forced expiratory volume

Change in forced vital capacity

Lung

+2 more

Secondary study objectives

Time of "gender adjustment" of PFT's normative values

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pulmonary Function in Transgender and Gender Diverse PatientsExperimental Treatment2 Interventions

Transgender and gender diverse (TGD) patients undergoing masculinizing or feminizing hormone therapies will have breathing tests to evaluate their lung function

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Plethysmography

2008

Completed Phase 4

~180

Spirometry

2017

Completed Phase 2

~12540