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Gender-Affirming Treatments and Lung Function Study

This study is looking at how gender-affirming hormone therapy might affect your lung function. Researchers will use special breathing tests called spirometry and plethysmography to measure changes in your lung volume and how much air you can breathe out. They will be looking for changes in these measurements over 18 months. This study is open to people aged 14 and older, of all genders, who are able to give informed consent (or have a parent/guardian consent for those under 18). The study is currently unclear on its recruitment status and plans to enroll 44 participants.

Study design
This study is an interventional study, meaning participants will receive a specific intervention (gender-affirming hormone therapy). It plans to enroll 44 participants.
What's involved
You would undergo pulmonary function tests (spirometry and plethysmography) at the start of the study, and then at 6, 12, and 18 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 18 months after the initial measurements.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05587751

Evaluation of Gender-Affirming Treatments on Pulmonary Function in Transgender and Gender Diverse Patients

Recruiting
NAAges 14+InterventionalBasic science
Mayo Clinic
~44 participants
Updated 2026-05-18 on ClinicalTrials.gov
What's tested:SpirometryPlethysmography

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in lung volume (Total Lung Capacity, Vital Capacity, Functional Residual Capacity, Residual Volume)
Measured over Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up
+4 more outcomes measured

Conditions

Hormonal Gender-Affirming Therapy

Explore related trials

Gender Dysphoria

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Gustavo Cortes Puentes, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Kayla Quinn, MS
[email protected]
800-752-1606
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change in lung volume (Total Lung Capacity, Vital Capacity, Functional Residual Capacity, Residual Volume)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 volumeBaseline, 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 capacityBaseline, 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 flowBaseline, 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 rateBaseline, 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