Hormonal Gender-Affirming TherapyNCT05587751
Evaluation of Gender-Affirming Treatments on Pulmonary Function in Transgender and Gender Diverse Patients
A study testing Spirometry and Plethysmography in people with Hormonal Gender-Affirming Therapy, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate whether undergoing gender affirming care will impact the way the lungs function. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Hormonal Gender-Affirming Therapy
- What is being tested?
- Spirometry and Plethysmography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Kayla L Macdonald, (507)538-0595, macdonald.kayla@mayo.edu
About this study
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.
- Conditions
- Hormonal Gender-Affirming Therapy
- Being tested
- Spirometry, Plethysmography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpirometryDiagnostic test
Pulmonary function test to measure lung function
PlethysmographyDiagnostic test
Pulmonary function test to measure lung volume
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Function in Transgender and Gender Diverse Patients | Experimental | Transgender and gender diverse (TGD) patients undergoing masculinizing or feminizing hormone therapies will have breathing tests to evaluate their lung function Receives: Diagnostic Test: Spirometry; Diagnostic Test: Plethysmography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lung volume (Total Lung Capacity, Vital Capacity, Functional Residual Capacity, Residual Volume)
The longitudinal changes in lung volumes after both masculinizing and feminizing hormone therapy in transgender and gender diverse (TGD) patients.
Measured: Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up
Change in forced expiratory volume
Measured by spirometry to determine the volume of air that can be exhaled in 1 second with a forced breath
Measured: Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up
Change in forced vital capacity
Measured by spirometry to determine the maximal amount of air that can be forcibly exhaled from the lungs after a full inhale, reported as liters (L)
Measured: Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up
Change in peak expiratory flow
Measured by a peak flow meter is the maximum forced expiratory flow, reported in liter per minute (L/min)
Measured: Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up
Change in maximal mid-expiratory flow rate
Measured by spirometry to determine the rate of airflow where half of the forced vital capacity is exhaled
Measured: Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up
Secondary outcomes (1)
Time of "gender adjustment" of PFT's normative values
The time of "gender adjustment" of PFT's 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.
Measured: Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start1 Feb 2023
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormonal Gender-Affirming TherapyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gustavo A. Cortes Puentes, Mayo Clinic
- Investigators
- Gustavo Cortes Puentes, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587751
- Sponsor's protocol ID
- 22-007173
- Status last verified
- May 2026
- First submitted
- 27 Sep 2022
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Gender-Affirming Treatments on Pulmonary Function in Transgender and Gender Diverse (TGD) Patients
- ClinicalTrials.gov ID
- NCT05587751
- Acronym / sponsor ID
- 22-007173
- Conditions
- Hormonal Gender-Affirming Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 20 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to evaluate whether undergoing gender affirming care will impact the way the lungs function.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Function in Transgender and Gender Diverse Patients | Experimental | Diagnostic Test: Spirometry, Diagnostic Test: PlethysmographyTransgender and gender diverse (TGD) patients undergoing masculinizing or feminizing hormone therapies will have breathing tests to evaluate their lung function |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (7 listed)
- 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):
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpirometryPulmonary function test to measure lung function | Diagnostic test | Pulmonary Function in Transgender and Gender Diverse Patients |
| PlethysmographyPulmonary function test to measure lung volume | Diagnostic test | Pulmonary Function in Transgender and Gender Diverse Patients |
Primary outcome
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
The longitudinal changes in lung volumes after both masculinizing and feminizing hormone therapy in transgender and gender diverse (TGD) patients.
Change in forced expiratory volume
Time frame: Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up
Measured by spirometry to determine the volume of air that can be exhaled in 1 second with a forced breath
Change in forced vital capacity
Time frame: Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up
Measured by spirometry to determine the maximal amount of air that can be forcibly exhaled from the lungs after a full inhale, reported as liters (L)
Change in peak expiratory flow
Time frame: Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up
Measured by a peak flow meter is the maximum forced expiratory flow, reported in liter per minute (L/min)
Change in maximal mid-expiratory flow rate
Time frame: Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up
Measured by spirometry to determine the rate of airflow where half of the forced vital capacity is exhaled
1 secondary outcome
Time of "gender adjustment" of PFT's normative values
Time frame: Baseline, 6-month Follow-Up, 12-month Follow-Up, 18-month Follow-Up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gustavo Cortes Puentes, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spirometry and Plethysmography in people with Hormonal Gender-Affirming Therapy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kayla Quinn, MS (800-752-1606, quinn.kayla2@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.