NCT05587751 · Mayo Clinic
Evaluation of Gender-Affirming Treatments on Pulmonary Function in Transgender and Gender Diverse Patients
What this study is about
The purpose of this research study is to evaluate whether undergoing gender affirming care will impact the way the lungs function.
View original scientific description
The purpose of this research study is to evaluate whether undergoing gender affirming care will impact the way the lungs function.
Interventions
DIAGNOSTIC_TEST
Spirometry
Pulmonary function test to measure lung function
DIAGNOSTIC_TEST
Plethysmography
Pulmonary function test to measure lung volume
Primary outcome measures
Change in lung volume (Total Lung Capacity, Vital Capacity, Functional Residual Capacity, Residual Volume)
Time frame: Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up
The longitudinal changes in lung volumes after both masculinizing and feminizing hormone therapy in transgender and gender diverse (TGD) patients.
Change in forced expiratory volume
Time frame: Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up
Measured by spirometry to determine the volume of air that can be exhaled in 1 second with a forced breath
Change in forced vital capacity
Time frame: Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up
Measured by spirometry to determine the maximal amount of air that can be forcibly exhaled from the lungs after a full inhale, reported as liters (L)
Change in peak expiratory flow
Time frame: Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up
Measured by a peak flow meter is the maximum forced expiratory flow, reported in liter per minute (L/min)
Change in maximal mid-expiratory flow rate
Time frame: Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up
Measured by spirometry to determine the rate of airflow where half of the forced vital capacity is exhaled
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Subjects speaking any language will be offered participation.
- Subjects capable of providing informed consent to the study. For those subjects younger than 18 years old who agree to participate in the study, informed consent will be obtained from patient's parents/guardian.
- Subjects capable of performing pulmonary function test (PFT) maneuvers, as per pulmonary function test laboratory protocol.
- Patients will be enrolled through the Mayo Clinic Rochester Transgender and Intersex
- Specialty Care Clinic (TISCC), once patient has decided to undergo hormonal gender-affirming therapies (pubertal blockers, and masculinizing or feminizing hormone therapies).
Exclusion criteria
- Subjects unable to provide consent, or subjects who do not agree to discuss the study with their parents/guardians.
- The presence of contraindications for pulmonary function testing including (these will be reviewed at the time of recruitment and prior to each spirometry associated with the study):
- Recent surgical procedures (\<3 months) that could be affected by lung function testing, including the following categories: Abdominal surgery, Eye surgery, Thoracic surgery, Ear surgery, Brain surgery, Vascular surgery.
- The presence of previously known respiratory disorders including pulmonary embolism (\<6 months), pleural effusion, pneumothorax, hemoptysis.
- Recent myocardial infarction (\<1 month), new cardiac arrythmia (\<3 months), recent cardiac pacemaker implantation (\<3 months).
- Heart failure symptoms, significant shortness of breath, tachycardia, or angina
- The presence of chronic pulmonary diseases that maybe associated with changes in pulmonary function overtime such as asthma, chronic obstructive pulmonary disease, or interstitial lung diseases.
Where
- Rochester, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 18, 2026 · Source of record for eligibility and locations