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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04195659
Other study ID # SP0052757
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 29, 2019
Est. completion date December 31, 2021

Study information

Verified date June 2022
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators hypothesize that masculinizing top surgery (e.g., mastectomy and chest masculinization) leads to an improvement in self-report chest dysphoria, gender dysphoria, and gender congruence in assigned-female-at-birth, transgender and non-binary youth and young adults. This is a prospective, observational study that will enroll assigned-female-at-birth, transmasculine spectrum individuals age 13 to 25 years old who are or are not undergoing top surgery. Participants will complete a set of standard of care questionnaires regarding their chest dysphoria (e.g., distress about the chest), gender dysphoria (e.g., distress about a gender identity that does not match assigned sex), and gender congruence (e.g., degree to which an individual feels they are living in their authentic appearance and gender identity). They will complete this same set of questionnaires either three months after their top surgery or three months after the initial set of surveys.


Recruitment information / eligibility

Status Completed
Enrollment 81
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender Female
Age group 13 Years to 25 Years
Eligibility Inclusion Criteria: - Assigned the female sex at birth - Affirmed gender identity of male, non-binary, or gender other than female - English-speaking - Undergoing top surgery or matches a top surgery participant on age and number of months on testosterone Exclusion Criteria: - Non English speaking - Unable to complete self-report questionnaires

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Mastectomy and chest masculinization
A surgical procedure in which the breasts are removed and the chest is given a masculine contour.

Locations

Country Name City State
United States Ann and Robert H Lurie Children's Hospital of Chicago Chicago Illinois
United States Northwestern University Chicago Illinois
United States University of Illinois Chicago Chicago Illinois

Sponsors (3)

Lead Sponsor Collaborator
Northwestern University Ann and Robert H. Lurie Children's Hospital of Chicago, University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Chest Dysphoria The disruption of individual comfort, physical functioning, and interpersonal relationships from a chest with breasts, as measured by the Chest Dysphoria Measure (Score 0-51, Higher number means greater chest dysphoria) Three month
Secondary Gender Dysphoria Distress about a gender identity that differs from assigned sex, measured by the Utrecht Gender Dysphoria Scale (Score 12-60, Higher number means greater gender dysphoria) Three month
Secondary Gender Congruence Feelings of living in an authentic gender identity and appearance, as measured by the Kozee Transgender Congruence Scale (Score 12-60, Higher number means greater gender congruence) Three month
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