NCT05166083

Brief Summary

The aim of the study is to follow acoustic and perceptual voice changes in trans men during hormone therapy and to examine the relationship between psychosocial and vocal characteristics and testosterone measured in routine follow-up in accordance with international follow-up guidelines.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 21, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

March 11, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2025

Completed
Last Updated

July 8, 2025

Status Verified

March 1, 2024

Enrollment Period

2.8 years

First QC Date

November 13, 2021

Last Update Submit

July 2, 2025

Conditions

Gender DysphoriaVoice Disorder Due to TranssexualismTransgender PersonsHormone Replacement Therapy

Keywords

Trans man voice, hormon therapy

Outcome Measures

Primary Outcomes (3)

  • Change in Self-perception of voice

    Transsexual Voice Questionnaire (TVQ-Female to male) Score Self-perception of voice masculinity (SPVM) Score

    change from baseline to the 4th dose of hormone treatment

  • Change in Self-perception of voice

    Transsexual Voice Questionnaire (TVQ-Female to male) Score Self-perception of voice masculinity (SPVM) Score

    change from baseline to the 8th dose of hormone treatment

  • Change in Self-perception of voice

    Transsexual Voice Questionnaire (TVQ-Female to male) Score Self-perception of voice masculinity (SPVM) Score

    change from 4th to the 8th dose of hormone treatment

Secondary Outcomes (21)

  • Change in Acoustic Voice Characteristics

    change from baseline to the 4th dose of hormone treatment

  • Change in Acoustic Voice Characteristics

    change from baseline to the 8th dose of hormone treatment

  • Change in Acoustic Voice Characteristics

    change from 4th to the 8th dose of hormone treatment

  • Changes in the person's severity of depression

    change from baseline to the 4th dose of hormone treatment

  • Changes in the person's severity of depression

    change from baseline to the 8th dose of hormone treatment

  • +16 more secondary outcomes

Study Arms (1)

Trans man

"Trans man" is assigned female at birth and identify as man

Other: Testosterone Hormon Therapy

Interventions

Testosterone Hormon TherapyOTHER

Testosterone isocaproate, ... ml, 8 doses, once per 21 days

Trans man

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Details"Trans man" is a person whose assigned sex at birth is female and who identifies himself as male.
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Trans men who are followed in Hacettepe University Hospital Endocrinology and Psychiatry Clinics.

You may qualify if:

  • Being diagnosed with "Gender Dysphoria" according to DSM 5
  • Having decided to start hormone therapy

You may not qualify if:

  • Diagnosis of vocal fold lesion in videolaryngostroboscopy evaluation
  • Having previously received voice therapy or undergone voice surgery
  • Having a systematic/or neurological disorder that may affect voice quality
  • Having had hormone therapy or still on hormone therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University, Speech and Language Therapy

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gender Dysphoria

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, PsychologicalMental Disorders

Study Officials

  • Fatma Esen AYDINLI, Assoc. Prof.

    Hacettepe University, Speech and Language Therapy Departmant

    STUDY DIRECTOR

  • Merve OGULMUS, SLP.

    Hacettepe University, Speech and Language Therapy

    STUDY CHAIR

  • Koray Baser, Assoc. Prof.

    Hacettepe Univeristy, Faculty of Medicine, Mental Health and Disease Department

    STUDY CHAIR

  • Bulent Okan YILDIZ, Prof.

    Hacettepe University, Faculty of Medicine, Endocrinology department

    STUDY CHAIR

  • Taner YILMAZ, Prof.

    Hacettepe University, Faculty of Medicine, Otorhinolaryngology department

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
8 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 13, 2021

First Posted

December 21, 2021

Study Start

March 11, 2022

Primary Completion

December 18, 2024

Study Completion

January 20, 2025

Last Updated

July 8, 2025

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)