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

NCT ID: NCT05587751

Last Updated: 2025-05-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2027-07-31

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Spirometry

Intervention Type: DIAGNOSTIC_TEST

Pulmonary function test to measure lung function

Plethysmography

Intervention Type: DIAGNOSTIC_TEST

Pulmonary function test to measure lung volume

Interventions

Spirometry

Pulmonary function test to measure lung function

Intervention Type: DIAGNOSTIC_TEST

Plethysmography

Pulmonary function test to measure lung volume

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Gustavo A. Cortes Puentes

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gustavo Cortes Puentes, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic Rochester

Rochester, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kayla Quinn, MS

Role: CONTACT

quinn.kayla2@mayo.edu

800-752-1606

Facility Contacts

Kayla L Macdonald

Role: primary

macdonald.kayla@mayo.edu

(507)538-0595

Other Identifiers

22-007173

Identifier Type: -

Identifier Source: org_study_id