Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05116293
Other study ID # STUDY00011644
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 1, 2021
Est. completion date December 31, 2024

Study information

Verified date March 2024
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This project will evaluate the effect of gender-affirming testosterone treatment on how other medications are processed by the body.


Description:

Gender-affirming hormone therapy may include testosterone, a hormone that the body creates and uses naturally. Testosterone is prepared as a medication that patients may take to increase hormone levels. Changes in testosterone concentrations in the body may affect how the body processes other medicines. The purpose of this study is to find out how testosterone therapy affects a single tracer dose of approved medicines in the blood (midazolam, digoxin, and acetaminophen) and to confirm testosterone treatment does not affect natural bacterial in the gut.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 12
Est. completion date December 31, 2024
Est. primary completion date February 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Self-identified trans* adult at least 18 years of age. - Not taking testosterone treatment currently. - Planning to start testosterone treatment through care provider for gender-affirming medical care. Exclusion Criteria: - Unwilling/unable to return for project follow-up visits. - Unwilling/unable to provide written informed consent.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Midazolam oral solution
Oral syrup
Digoxin Oral Tablet
Oral tablet
Acetaminophen Oral Tablet
Oral tablet

Locations

Country Name City State
United States University of Washington Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary midazolam AUC ratio (treatment/control) ratio of the area under of the plasma concentration time curve (AUC) of midazolam in the presence to absence of gender-affirming testosterone treatment. 0-48 hours
Secondary midazolam Cmax ratio (treatment/control) ratio of the maximum plasma concentration (Cmax) of midazolam in the presence to absence of gender-affirming testosterone treatment 0-48 hours
See also
  Status Clinical Trial Phase
Completed NCT04036500 - Transgender Estradiol Early Phase 1
Terminated NCT04534881 - Effect of Progesterone on Testosterone Concentrations and Breast Development in Transwomen Phase 2
Recruiting NCT05469204 - Effect of Estrogen Treatment on Drug Metabolism and Transport
Not yet recruiting NCT05337865 - Transgender Observational Performance
Completed NCT04448418 - The Impact of COVID-19 Outbreak on Trans-population's Health in Italy
Recruiting NCT05166083 - Investigation of the Perceptual and Acoustic Voice in Trans Man
Not yet recruiting NCT05927350 - Research Participation With Transgender and Gender-Diverse Youth
Recruiting NCT04515472 - Effect of Gender Affirming Hormone Therapy on Glucose Metabolism Early Phase 1
Not yet recruiting NCT06177600 - TransHealthGUIDE: Transforming Health for Gender-Diverse Youth N/A
Completed NCT03864913 - Comparing Subcutaneous Testosterone to Intramuscular Testosterone in Gender Affirming Care of Transgender Male Adolescents Early Phase 1
Recruiting NCT05924217 - Gynecology Beyond Gender: Cervical Cancer Screening in Transgender Men in France
Completed NCT05187442 - The Experiences of Erotic and Sexual Risk of Transgender Men: Exploratory Research Design
Completed NCT03120936 - The Stay Study: A Demonstration Project Advancing PrEP Delivery in the San Francisco Bay Area Transgender Community Phase 4
Recruiting NCT04478760 - Trans & Non-binary Reference Intervals While on Hormone Therapy Study