Recruiting

Gender Affirming Care

Sponsor:

Mayo Clinic

Code:

NCT05587751

Conditions

Hormonal Gender-Affirming Therapy

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Not accepted

Interventions

Spirometry

Plethysmography

Study Details

Brief summary:

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

Conditions

Hormonal Gender-Affirming Therapy

Study ID

NCT05587751

Start date

Feb 1, 2023

Status verified date

May, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

44 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Pulmonary Function in Transgender and Gender Diverse Patients

Transgender and gender diverse (TGD) patients undergoing masculinizing or feminizing hormone therapies will have breathing tests to evaluate their lung function

Interventions

Spirometry

Pulmonary function test to measure lung function

Plethysmography

Pulmonary function test to measure lung volume

Primary outcome measure

  • 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 ]
  • Change in forced expiratory volume [ Time Frame: Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up ]
  • Change in forced vital capacity [ Time Frame: Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up ]
  • Change in peak expiratory flow [ Time Frame: Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up ]
  • Change in maximal mid-expiratory flow rate [ Time Frame: Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up ]

Central Contacts and Locations

Central contacts

Kayla Quinn, MS

800-752-1606quinn.kayla2@mayo.edu

Locations

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Kayla L Macdonald

(507)538-0595macdonald.kayla@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

May 18, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-05-18.