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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT05587751
Status
Recruiting

Conditions

  • Hormonal Gender-Affirming Therapy

Eligibility Criteria

Sex
ALL
Age
14 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Spirometry — DIAGNOSTIC_TEST
    Pulmonary function test to measure lung function
  • Plethysmography — DIAGNOSTIC_TEST
    Pulmonary function test to measure lung volume

Study Details

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

Key Dates

Start date
Feb 1, 2023
Status verified
May 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
44 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Pulmonary Function in Transgender and Gender Diverse Patients
    Transgender and gender diverse (TGD) patients undergoing masculinizing or feminizing hormone therapies will have breathing tests to evaluate their lung function

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic RochesterRochesterMinnesota55905
Kayla L Macdonald
(507)538-0595

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