NCT07252687

Brief 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. 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
55mo left

Started Nov 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Nov 2025Nov 2030

First Submitted

Initial submission to the registry

November 14, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 28, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

November 30, 2025

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2030

Last Updated

March 6, 2026

Status Verified

November 1, 2025

Enrollment Period

4.9 years

First QC Date

November 14, 2025

Last Update Submit

March 4, 2026

Conditions

Keywords

transgenderbreastdysphoriatrans malenon binarygenderdiverse

Outcome Measures

Primary Outcomes (1)

  • 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.

    From enrollment to the end of observation after 2 years

Interventions

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.

Eligibility Criteria

Age16 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailstrans men and gender diverse persons
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Referral to the medical University of Innsbruck Hospital or a cooperating center

You may qualify if:

  • AFAB (Assigned Female At Birth)
  • before starting GAHT
  • before mastectomy

You may not qualify if:

  • Ongoing GAHT
  • Mastectomy already performed
  • Lack of capacity to give consent
  • Insufficient knowledge of German

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Innsbruck

Innsbruck, Austria

RECRUITING

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 28, 2025

Study Start

November 30, 2025

Primary Completion (Estimated)

November 1, 2030

Study Completion (Estimated)

November 1, 2030

Last Updated

March 6, 2026

Record last verified: 2025-11

Locations