Gender DysphoriaNCT04195659
Chest Dysphoria in Transmasculine Spectrum Adolescents
An observational study of Gender Dysphoria, run by Northwestern University at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 25 years, women only
- Conditions the study is for
- Gender Dysphoria
- What is being tested?
- Mastectomy and chest masculinization
- Type of treatment
- Surgery or procedure
- How many people
- 81 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Oct 2019to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 13 to 25 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Top surgery participants will be recruited from plastic surgery practices at Northwestern University, the Ann and Robert H Lurie Children's Hospital of Chicago, and the University of Illinois Chicago. Matched controls will be recruited from the Lurie Children's Hospital Gender and Sex Development Program.
Who may be able to join
- 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
Who cannot join
- Non English speaking
- Unable to complete self-report questionnaires
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Ann and Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Northwestern University
Chicago, Illinois, 60611
University of Illinois Chicago
Chicago, Illinois, 60612
About this study
Official title: The Effect of Top Surgery on Chest Dysphoria in Assigned-Female-At-Birth, Transmasculine Spectrum Youth and Young Adults
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.
- Conditions
- Gender Dysphoria
- Being tested
- Mastectomy and chest masculinization
- Medical subject headings
- Gender Dysphoria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mastectomy and chest masculinizationProcedure or surgery
A surgical procedure in which the breasts are removed and the chest is given a masculine contour.
| Study group | Role | What they receive |
|---|---|---|
| Top Surgery | Individuals assigned the female sex at birth, who identify as a gender other than female, are between the ages of 13 and 25 years, and who are undergoing mastectomy and chest masculinization in one of three plastic surgery practices in Chicago. Receives: Procedure: Mastectomy and chest masculinization | |
| Control | Individuals assigned the female sex at birth, who identify as a gender other than female, are between the ages of 13 and 25 years, were seen in a gender development clinic in Chicago, and who are not planning to undergo top surgery. Controls will be matched with top surgery patients on age and number of months of testosterone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Three month
Secondary outcomes (2)
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)
Measured: Three month
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)
Measured: Three month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start29 Oct 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender DysphoriaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Ann & Robert H Lurie Children's Hospital of Chicago, University of Illinois Chicago
- Responsible party
- Principal investigator, Sumanas Jordan, Northwestern University
- Investigators
- Sumanas W Jordan, MD PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04195659
- Sponsor's protocol ID
- SP0052757
- Status last verified
- Jun 2022
- First submitted
- 10 Dec 2019
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Top Surgery on Chest Dysphoria in Assigned-Female-At-Birth, Transmasculine Spectrum Youth and Young Adults
- ClinicalTrials.gov ID
- NCT04195659
- Acronym / sponsor ID
- SP0052757
- Conditions
- Gender Dysphoria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Ann & Robert H Lurie Children's Hospital of Chicago, University of Illinois Chicago
- Study start
- 29 Oct 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 12 Dec 2019 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Top Surgery | – | Procedure: Mastectomy and chest masculinizationIndividuals assigned the female sex at birth, who identify as a gender other than female, are between the ages of 13 and 25 years, and who are undergoing mastectomy and chest masculinization in one of three plastic surgery practices in Chicago. |
| Control | – | –Individuals assigned the female sex at birth, who identify as a gender other than female, are between the ages of 13 and 25 years, were seen in a gender development clinic in Chicago, and who are not planning to undergo top surgery. Controls will be matched with top surgery patients on age and number of months of testosterone. |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Top surgery participants will be recruited from plastic surgery practices at Northwestern University, the Ann and Robert H Lurie Children's Hospital of Chicago, and the University of Illinois Chicago. Matched controls will be recruited from the Lurie Children's Hospital Gender and Sex Development Program.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Non English speaking
- Unable to complete self-report questionnaires
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 |
|---|---|---|
| Mastectomy and chest masculinizationA surgical procedure in which the breasts are removed and the chest is given a masculine contour. | Procedure or surgery | Top Surgery |
Primary outcome
Chest Dysphoria
Time frame: Three month
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)
2 secondary outcomes
Gender Dysphoria
Time frame: Three month
Gender Congruence
Time frame: Three month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Sumanas W Jordan, MD PhD principal investigator
Northwestern University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gender Dysphoria, run by Northwestern University at 3 sites 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 10 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chest Dysphoria (time frame: Three month). 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 10 Jun 2022.