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NCT05587751
Evaluating the Impact of Gender-Affirming Treatments on Pulmonary Function in Transgender and Gender Diverse (TGD) Patients
NA trial testing Spirometry in Hormonal Gender-Affirming Therapy in 44 participants. Currently enrolling.
1 July 2027
Quick facts
| Lead sponsor | Mayo Clinic |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 44 |
| Start date | 1 February 2023 |
| Primary completion | 1 July 2027 |
| Estimated completion | 1 July 2027 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Spirometry
- Plethysmography
Conditions studied
- Hormonal Gender-Affirming Therapy — all drugs for Hormonal Gender-Affirming Therapy →
Sponsor
Mayo Clinic
Who can join
14 and older, any sex, with Hormonal Gender-Affirming Therapy. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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
Sponsor's own description
The purpose of this research study is to evaluate whether undergoing gender affirming care will impact the way the lungs function.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05587751
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05587751 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mayo Clinic
- Last refreshed: 15 May 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05587751.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing