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

Recruiting
14 years of age
Both
Phase N/A

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Overview

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

Eligibility

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.

Study details

Hormonal Gender-Affirming Therapy

NCT05587751

Mayo Clinic

29 April 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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