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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in forced expiratory volume

Change in forced vital capacity

Lung

+2 more

Secondary outcome measures

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

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

Spirometry

2017

Completed Phase 2

~11540

Plethysmography

2008

Completed Phase 4

~180

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,213 Previous Clinical Trials

3,766,967 Total Patients Enrolled

Gustavo Cortes Puentes, MDPrincipal InvestigatorMayo Clinic

1 Previous Clinical Trials

6 Total Patients Enrolled

Media Library

Gender-Affirming Treatments (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05587751 — N/A

Hormonal Therapy Research Study Groups: Pulmonary Function in Transgender and Gender Diverse Patients

Hormonal Therapy Clinical Trial 2023: Gender-Affirming Treatments Highlights & Side Effects. Trial Name: NCT05587751 — N/A

Gender-Affirming Treatments (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05587751 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research initiative currently open for enrollment?

"According to clinicaltrials.gov, this medical trial is not actively recruiting patients anymore; the post was initially uploaded on December 1st 2022 and last updated November 7th 2022. However, there are other trials currently accepting enrollees at present."

Answered by AI