Recruiting NCT05587751

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

No phase Interventional Hormonal Gender-Affirming Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Spirometry, Plethysmography.
Who it may be relevant to: Registry conditions: Hormonal Gender-Affirming Therapy. Basic parameters: from 14 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

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

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

Diagnostic test Spirometry
Pulmonary function test to measure lung function
Diagnostic test Plethysmography
Pulmonary function test to measure lung volume

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]

Secondary outcome measures (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]

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).

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

United States · 1 center

NCT: NCT05587751 · 22-007173