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NCT Number: NCT05587751

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

The purpose of this research study is to evaluate whether undergoing gender affirming care will impact the way the lungs function.

Recruiting

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Key information

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Kayla L Macdonald

CONTACT

[email protected]

(507)538-0595

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Spirometry

Diagnostic Test

Pulmonary function test to measure lung function

Plethysmography

Diagnostic Test

Pulmonary function test to measure lung volume

Primary outcomes

  1. 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.

  2. 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

  3. 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)

  4. 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)

  5. 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

Secondary outcomes

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

    Time frame: Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up

    The time of "gender adjustment" of PFT's normative values (PFTs results correlate most closely with patient's gender than with their sex-assigned at birth) in response to gender-affirming hormone therapy in transgender and gender diverse (TGD) patients.

Study contacts

Contact information is provided by the study sponsor or research team.

Kayla Quinn, MS

CONTACT

[email protected]

800-752-1606

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Evaluating the Impact of Gender-Affirming Treatments on Pulmonary Function in Transgender and Gender Diverse (TGD) Patients

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Oct 20, 2022
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.