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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
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 moreSecondary 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
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,362 Previous Clinical Trials
3,065,917 Total Patients Enrolled
Gustavo Cortes Puentes, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
6 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can perform the required breathing tests for lung function.I haven't had any major surgeries in the last 3 months that could affect breathing tests.I have had lung problems like clots, fluid around lungs, collapsed lung, or coughing up blood recently.I have not had a heart attack, new heart rhythm problem, or pacemaker implant in the last 3 months.I experience significant heart-related symptoms like shortness of breath or chest pain.I have a long-term lung condition like asthma or COPD.I can give my consent, or if under 18, my parents/guardians can.I am a patient at the Mayo Clinic TISCC and have decided to start hormone therapy for gender affirmation.
Research Study Groups:
This trial has the following groups:- Group 1: Pulmonary Function in Transgender and Gender Diverse Patients
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.