An Evaluation of Gender-Affirming Treatments on Pulmonary Function in Transgender and Gender Diverse (TGD) Patients


About this study

The purpose of this study is to evaluate the longitudinal changes in lung volumes and spirometry parameters, after both masculinizing and feminizing hormone therapy in transgender and gender diverse (TGD) patients. Also, to determine the time of “gender adjustment” of PFT’s (pulmonary function test) normative values (PFTs results correlate most closely with patient’s gender than with their sex-assigned at birth) in response to gender-affirming hormone therapy in transgender and gender diverse (TGD) patients. Additionally, to implement a personalized approach to PFT interpretation using gender-appropriate normative values in transgender and gender diverse (TGD) patients, during the transition period and after attaining end points of gender transition.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age ≥ 14 years old. 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.

Eligibility last updated 7/8/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Gustavo Cortes Puentes, M.D.

Open for enrollment

Contact information:

Kayla MacDonald

(507) 538-0595

More information


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