RecruitingNot Applicable

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

United States44 participantsStarted 2023-02-01

Plain-language summary

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

Who can participate

Age range

14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 implant…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in lung volume (Total Lung Capacity, Vital Capacity, Functional Residual Capacity, Residual Volume)