TransgenderTRANSBREASTNCT07252687
The Effect of Gender-affirmative Measures on Breast Perception in Trans Men
An observational study of Transgender and Gender Dysphoria in Adolescents and Adults, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
Breast dysphoria in transmasculine or genderdiverse individuals is a distinct psychological burden associated with depression, anxiety and suicidality. The aim is to systematically investigate the effect of GAHT (gender-affirming hormone therapy) and mastectomy on this form of dysphoria. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Transgender, Gender Dysphoria in Adolescents and Adults
- What is being tested?
- quality of life questionnaire- iTransQoL, chest dysphoria measure
- How many people
- 100 participants
- Where
- 1 siteAustria
- Study dates
- 30 Nov 2025to Nov 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 years and older
- Women only
- Child, Adult, Older adult
Study population: Referral to the medical University of Innsbruck Hospital or a cooperating center
Who may be able to join
- AFAB (Assigned Female At Birth)
- before starting GAHT
- before mastectomy
Who cannot join
- Ongoing GAHT
- Mastectomy already performed
- Lack of capacity to give consent
- Insufficient knowledge of German
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University Innsbruck
Innsbruck
Katharina Feil, +43 512 504 26276, katharina.feil@i-med.ac.at
About this study
Official title: The Effect of Gender-affirmative Measures on Breast Perception in Trans Men (TRANSBREAST) - a Prospective Cohort Study
Breast dysphoria in transmasculine or genderdiverse individuals is a distinct psychological burden associated with depression, anxiety and suicidality. The aim is to systematically investigate the effect of GAHT (gender-affirming hormone therapy) and mastectomy on this form of dysphoria.
The primary objective of this study is to analyse and investigate the psychological and physical effects of breast development on trans men or genderdiverse individuals.
A secondary objective is to determine the extent to which the stress affects the well-being of trans men depending on the coping strategies used (binding vs. taping).
- Being tested
- quality of life questionnaire- iTransQoL, chest dysphoria measure
- Keywords
- transgender, breastdysphoria, trans male, non binary, genderdiverse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quality of life questionnaire- iTransQoL, chest dysphoria measureOther
Before starting treatment, participants should complete the Chest Dysphoria Measure and iTransQoL questionnaires (=time point 0). The second time point for completing the questionnaires again is 3 months after starting hormone therapy. Subsequently, the questionnaires should be completed a third time after breast-affirming surgery. The final survey takes place two years after time point 0, or 6 months after the previous survey.
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest Dysphoria Measure Score
Chest Dysphoria Measure Score before GAHT, during GAHT, and after mastectomy. Possible chest dysphoria scores range from 0 to 51, with higher scores indicating greater distress.
Measured: From enrollment to the end of observation after 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start30 Nov 2025
- Primary completionNov 2030 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TransgenderStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252687
- Sponsor's protocol ID
- 1125/2025
- Acronym
- TRANSBREAST
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 6 Mar 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Gender-affirmative Measures on Breast Perception in Trans Men (TRANSBREAST) - a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07252687
- Acronym / sponsor ID
- TRANSBREAST / 1125/2025
- Keywords
- transgender, breastdysphoria, trans male, non binary, genderdiverse
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 30 Nov 2025 (actual)
- Primary completion
- Nov 2030 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 28 Nov 2025 (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.
Breast dysphoria in transmasculine or genderdiverse individuals is a distinct psychological burden associated with depression, anxiety and suicidality. The aim is to systematically investigate the effect of GAHT (gender-affirming hormone therapy) and mastectomy on this form of dysphoria.
The primary objective of this study is to analyse and investigate the psychological and physical effects of breast development on trans men or genderdiverse individuals.
A secondary objective is to determine the extent to which the stress affects the well-being of trans men depending on the coping strategies used (binding vs. taping).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- Referral to the medical University of Innsbruck Hospital or a cooperating center
Key inclusion criteria (3 listed)
- AFAB (Assigned Female At Birth)
- before starting GAHT
- before mastectomy
Key exclusion criteria (4 listed)
- Ongoing GAHT
- Mastectomy already performed
- Lack of capacity to give consent
- Insufficient knowledge of German
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 |
|---|---|---|
| quality of life questionnaire- iTransQoL, chest dysphoria measureBefore starting treatment, participants should complete the Chest Dysphoria Measure and iTransQoL questionnaires (=time point 0). The second time point for completing the questionnaires again is 3 months after starting hormone therapy. Subsequently, the questionnaires should be completed a third time after breast-affirming surgery. The final survey takes place two years after time point 0, or 6 months after the previous survey. | Other | – |
Primary outcome
Chest Dysphoria Measure Score
Time frame: From enrollment to the end of observation after 2 years
Chest Dysphoria Measure Score before GAHT, during GAHT, and after mastectomy. Possible chest dysphoria scores range from 0 to 51, with higher scores indicating greater distress.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transgender and Gender Dysphoria in Adolescents and Adults, run by Medical University Innsbruck at 1 site in Austria.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katharina Feil (+4351250423276, katharina.feil@i-med.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chest Dysphoria Measure Score (time frame: From enrollment to the end of observation after 2 years). 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 6 Mar 2026.