Evaluating how gender-affirming treatments affect lung function in transgender and gender diverse patients
Evaluating the Impact of Gender-Affirming Treatments on Pulmonary Function in Transgender and Gender Diverse (TGD) Patients
This study is testing how gender-affirming treatments affect lung function in transgender and gender diverse individuals to see if their breathing improves after starting hormone therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT05587751 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the impact of gender-affirming treatments on pulmonary function in transgender and gender diverse individuals. Participants will undergo pulmonary function tests, including spirometry and plethysmography, to evaluate lung performance before and after receiving hormonal gender-affirming therapies. The study will enroll patients from the Mayo Clinic Rochester Transgender and Intersex Specialty Care Clinic who have decided to pursue these treatments. The research seeks to provide insights into the respiratory health of this population.
Who should consider this trial
Good fit: Ideal candidates include transgender and gender diverse individuals who are planning to start hormonal gender-affirming therapies and can perform pulmonary function tests.
Not a fit: Patients who are unable to provide informed consent or have contraindications for pulmonary function testing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of respiratory health in transgender and gender diverse patients undergoing hormone therapy.
How similar studies have performed: While there is limited research specifically on pulmonary function in this context, similar studies on gender-affirming treatments have shown promising outcomes in other health aspects.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Gustavo Cortes Puentes, MD — Mayo Clinic
- Study coordinator: Kayla Quinn, MS
- Email: quinn.kayla2@mayo.edu
- Phone: 800-752-1606
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.