Gender DysphoriaNCT05166083
Investigation of the Perceptual and Acoustic Voice in Trans Man
An observational study of Gender Dysphoria and Voice Disorder Due to Transsexualism, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gender Dysphoria, Voice Disorder Due to Transsexualism, Transgender Persons
- What is being tested?
- Testosterone Hormon Therapy
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Mar 2022to 20 Jan 2025
- How long will I take part?
- 8 Months
- 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 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Trans men who are followed in Hacettepe University Hospital Endocrinology and Psychiatry Clinics.
Who may be able to join
- Being diagnosed with "Gender Dysphoria" according to DSM 5
- Having decided to start hormone therapy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University, Speech and Language Therapy
Ankara
About this study
Official title: Investigation of the Perceptual and Acoustic Characteristic of Voice in Trans Man
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.
Read the detailed description
Trans men who have completed the evaluation and follow-up procedure and decided to use sex hormones will be included in the study. Participants will be followed for 8 doses of sex hormone use. Acoustic and perceptual changes in voice will be monitored at baseline (before hormone use), 4th dose, and 8th dose. The relationship between testosterone and psychosocial and vocal characteristics will be examined. At the baseline of the study, participants will be evaluated with Videolaryngostroboscopy (VLS). As a result of VLS, perceptual and acoustic voice evaluation will be made to the participants who are determined to have healthy vocal folds. During routine psychiatric visits, participants will be asked to fill in self-report scales. Endocrinological routine evaluations will be applied to the participants and the data of these routine evaluations will be used in the study. All of these evaluations (perceptual and acoustic voice evaluation, endocrinological and psychiatric evaluations) will be repeated at the 4. and 8. doses of the hormone therapy, except for the VLS evaluation.
IBM SPSS Statistics 26.0 and Microsoft Excel 365 programs will be used for statistical analysis. The number of participants to be included in the study was calculated using the G Power 3.1 program. In the analysis, the number of participants was determined as 28 (G power=0.80, α =0.05). The normal distribution of the data will be examined by visual and analytical methods (Shapiro-Wilk test, Kolmogorov-Smirnov test).The analysis of each variable measured at three time points will be evaluated using ANOVA if the assumptions of parametric tests are met, and using the Friedman test if the assumptions of parametric tests are not met. When the parametric conditions are met Paired t test will be used to compare the measurement values, and when the parametric conditions are not met, the Wilcoxon signed-rank test will be used. Multiple Regression Analysis will be used to determine the factors affecting the person's own perception of voince. Finally, statistical significance level was accepted as p<0.05.
- Conditions
- Gender Dysphoria, Voice Disorder Due to Transsexualism, Transgender Persons, Hormone Replacement Therapy
- Being tested
- Testosterone Hormon Therapy
- Keywords
- Trans man voice, hormon therapy
- Medical subject headings
- Gender Dysphoria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone Hormon TherapyOther
Testosterone isocaproate, ... ml, 8 doses, once per 21 days
| Study group | Role | What they receive |
|---|---|---|
| Trans man | "Trans man" is assigned female at birth and identify as man Receives: Other: Testosterone Hormon Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Self-perception of voice
Transsexual Voice Questionnaire (TVQ-Female to male) Score Self-perception of voice masculinity (SPVM) Score
Measured: 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
Measured: 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
Measured: change from 4th to the 8th dose of hormone treatment
Secondary outcomes (21)
Change in Acoustic Voice Characteristics
Digital recordings will be made using the Computerized Speech Lab (KayPENTAX) while performing the following tasks: sustained vowel /a:/, sponteous speech and "Pinokyo passage" reading. Voice recordings will be analyzed using the Real-Time Pitch Program and the Multidimensional Voice Program for measure F0, Mean F0, Jitter percent, Shimmer Percent, and noise-to-harmonic ratio (NHR).
Measured: change from baseline to the 4th dose of hormone treatment
Change in Acoustic Voice Characteristics
Digital recordings will be made using the Computerized Speech Lab (KayPENTAX) while performing the following tasks: sustained vowel /a:/, sponteous speech and "Pinokyo passage" reading. Voice recordings will be analyzed using the Real-Time Pitch Program and the Multidimensional Voice Program for measure F0, Mean F0, Jitter percent, Shimmer Percent, and noise-to-harmonic ratio (NHR).
Measured: change from baseline to the 8th dose of hormone treatment
Change in Acoustic Voice Characteristics
Digital recordings will be made using the Computerized Speech Lab (KayPENTAX) while performing the following tasks: sustained vowel /a:/, sponteous speech and "Pinokyo passage" reading. Voice recordings will be analyzed using the Real-Time Pitch Program and the Multidimensional Voice Program for measure F0, Mean F0, Jitter percent, Shimmer Percent, and noise-to-harmonic ratio (NHR).
Measured: change from 4th to the 8th dose of hormone treatment
Changes in the person's severity of depression
- Beck depression inventory (BDI)
Measured: change from baseline to the 4th dose of hormone treatment
Changes in the person's severity of depression
- Beck depression inventory (BDI)
Measured: change from baseline to the 8th dose of hormone treatment
Changes in the person's severity of depression
- Beck depression inventory (BDI)
Measured: change from 4th to the 8th dose of hormone treatment
Changes in the person's perception of support
- Multidimensional Scale of Perceived Social Support.
Measured: change from baseline to the 4th dose of hormone treatment
Changes in the person's perception of support
- Multidimensional Scale of Perceived Social Support.
Measured: change from baseline to the 8th dose of hormone treatment
Changes in the person's perception of support
- Multidimensional Scale of Perceived Social Support.
Measured: change from 4th to the 8th dose of hormone treatment
Changes in the person's anxiety level
- State-trait anxiety Inventory
Measured: change from baseline to the 4th dose of hormone treatment
Changes in the person's anxiety level
- State-trait anxiety Inventory
Measured: change from baseline to the 8th dose of hormone treatment
Changes in the person's anxiety level
- State-trait anxiety Inventory
Measured: change from 4th to the 8th dose of hormone treatment
Changes in the person's gender perception and gender transition process
- Transition questionnaire: The Transition Questionnaire is a self-report instrument that collects information on an individual's self-perception of status about the social and medical steps in the process of gender transition.
Measured: change from baseline to the 4th dose of hormone treatment
Changes in the person's gender perception and gender transition process
- Transition questionnaire: The Transition Questionnaire is a self-report instrument that collects information on an individual's self-perception of status about the social and medical steps in the process of gender transition.
Measured: change from baseline to the 8th dose of hormone treatment
Changes in the person's gender perception and gender transition process
- Transition questionnaire: The Transition Questionnaire is a self-report instrument that collects information on an individual's self-perception of status about the social and medical steps in the process of gender transition.
Measured: change from 4th to the 8th dose of hormone treatment
Changes in the person's body image perception
-Body cathexis scale
Measured: change from baseline to the 4th dose of hormone treatment
Changes in the person's body image perception
-Body cathexis scale
Measured: change from baseline to the 8th dose of hormone treatment
Changes in the person's body image perception
-Body cathexis scale
Measured: change from 4th to the 8th dose of hormone treatment
Change in testosterone level
Testosterone level measurement
Measured: change from baseline to the 4th dose of hormone treatment
Change in testosterone level
Testosterone level measurement
Measured: change from baseline to the 8th dose of hormone treatment
Change in testosterone level
Testosterone level measurement
Measured: change from 4th to the 8th dose of hormone treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start11 Mar 2022
- Primary completion18 Dec 2024
- Study completion20 Jan 2025
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 Hacettepe 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
- 26 participants (actual)
- Target duration
- 8 Months
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MERVE OGULMUS UYSAL, Hacettepe University
- Investigators
- Fatma Esen AYDINLI, Assoc. Prof., Study director, Hacettepe University, Speech and Language Therapy DepartmantMerve OGULMUS, SLP., Study chair, Hacettepe University, Speech and Language TherapyKoray Baser, Assoc. Prof., Study chair, Hacettepe Univeristy, Faculty of Medicine, Mental Health and Disease DepartmentBulent Okan YILDIZ, Prof., Study chair, Hacettepe University, Faculty of Medicine, Endocrinology departmentTaner YILMAZ, Prof., Study chair, Hacettepe University, Faculty of Medicine, Otorhinolaryngology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05166083
- Sponsor's protocol ID
- HUSLPTRANSMANVOICE
- Status last verified
- Mar 2024
- First submitted
- 13 Nov 2021
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Perceptual and Acoustic Characteristic of Voice in Trans Man
- ClinicalTrials.gov ID
- NCT05166083
- Acronym / sponsor ID
- HUSLPTRANSMANVOICE
- Conditions
- Gender Dysphoria, Voice Disorder Due to Transsexualism, Transgender Persons, Hormone Replacement Therapy
- Keywords
- Trans man voice, hormon therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 21 Dec 2021 (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 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.
Detailed description
Trans men who have completed the evaluation and follow-up procedure and decided to use sex hormones will be included in the study. Participants will be followed for 8 doses of sex hormone use. Acoustic and perceptual changes in voice will be monitored at baseline (before hormone use), 4th dose, and 8th dose. The relationship between testosterone and psychosocial and vocal characteristics will be examined. At the baseline of the study, participants will be evaluated with Videolaryngostroboscopy (VLS). As a result of VLS, perceptual and acoustic voice evaluation will be made to the participants who are determined to have healthy vocal folds. During routine psychiatric visits, participants will be asked to fill in self-report scales. Endocrinological routine evaluations will be applied to the participants and the data of these routine evaluations will be used in the study. All of these evaluations (perceptual and acoustic voice evaluation, endocrinological and psychiatric evaluations) will be repeated at the 4. and 8. doses of the hormone therapy, except for the VLS evaluation.
IBM SPSS Statistics 26.0 and Microsoft Excel 365 programs will be used for statistical analysis. The number of participants to be included in the study was calculated using the G Power 3.1 program. In the analysis, the number of participants was determined as 28 (G power=0.80, α =0.05). The normal distribution of the data will be examined by visual and analytical methods (Shapiro-Wilk test, Kolmogorov-Smirnov test).The analysis of each variable measured at three time points will be evaluated using ANOVA if the assumptions of parametric tests are met, and using the Friedman test if the assumptions of parametric tests are not met. When the parametric conditions are met Paired t test will be used to compare the measurement values, and when the parametric conditions are not met, the Wilcoxon signed-rank test will be used. Multiple Regression Analysis will be used to determine the factors affecting the person's own perception of voince. Finally, statistical significance level was accepted as p<0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trans man | – | Other: Testosterone Hormon Therapy"Trans man" is assigned female at birth and identify as man |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Trans men who are followed in Hacettepe University Hospital Endocrinology and Psychiatry Clinics.
Key inclusion criteria (2 listed)
- Being diagnosed with "Gender Dysphoria" according to DSM 5
- Having decided to start hormone therapy
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Testosterone Hormon TherapyTestosterone isocaproate, ... ml, 8 doses, once per 21 days | Other | Trans man |
Primary outcome
Change in Self-perception of voice
Time frame: change from baseline to the 4th dose of hormone treatment
Transsexual Voice Questionnaire (TVQ-Female to male) Score Self-perception of voice masculinity (SPVM) Score
Change in Self-perception of voice
Time frame: change from baseline to the 8th dose of hormone treatment
Transsexual Voice Questionnaire (TVQ-Female to male) Score Self-perception of voice masculinity (SPVM) Score
Change in Self-perception of voice
Time frame: change from 4th to the 8th dose of hormone treatment
Transsexual Voice Questionnaire (TVQ-Female to male) Score Self-perception of voice masculinity (SPVM) Score
21 secondary outcomes
Change in Acoustic Voice Characteristics
Time frame: change from baseline to the 4th dose of hormone treatment
Change in Acoustic Voice Characteristics
Time frame: change from baseline to the 8th dose of hormone treatment
Change in Acoustic Voice Characteristics
Time frame: change from 4th to the 8th dose of hormone treatment
Changes in the person's severity of depression
Time frame: change from baseline to the 4th dose of hormone treatment
Changes in the person's severity of depression
Time frame: change from baseline to the 8th dose of hormone treatment
Changes in the person's severity of depression
Time frame: change from 4th to the 8th dose of hormone treatment
Changes in the person's perception of support
Time frame: change from baseline to the 4th dose of hormone treatment
Changes in the person's perception of support
Time frame: change from baseline to the 8th dose of hormone treatment
Changes in the person's perception of support
Time frame: change from 4th to the 8th dose of hormone treatment
Changes in the person's anxiety level
Time frame: change from baseline to the 4th dose of hormone treatment
Changes in the person's anxiety level
Time frame: change from baseline to the 8th dose of hormone treatment
Changes in the person's anxiety level
Time frame: change from 4th to the 8th dose of hormone treatment
Changes in the person's gender perception and gender transition process
Time frame: change from baseline to the 4th dose of hormone treatment
Changes in the person's gender perception and gender transition process
Time frame: change from baseline to the 8th dose of hormone treatment
Changes in the person's gender perception and gender transition process
Time frame: change from 4th to the 8th dose of hormone treatment
Changes in the person's body image perception
Time frame: change from baseline to the 4th dose of hormone treatment
Changes in the person's body image perception
Time frame: change from baseline to the 8th dose of hormone treatment
Changes in the person's body image perception
Time frame: change from 4th to the 8th dose of hormone treatment
Change in testosterone level
Time frame: change from baseline to the 4th dose of hormone treatment
Change in testosterone level
Time frame: change from baseline to the 8th dose of hormone treatment
Change in testosterone level
Time frame: change from 4th to the 8th dose of hormone treatment
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 8 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Fatma Esen AYDINLI, Assoc. Prof. study director
Hacettepe University, Speech and Language Therapy Departmant
Merve OGULMUS, SLP. study chair
Hacettepe University, Speech and Language Therapy
Koray Baser, Assoc. Prof. study chair
Hacettepe Univeristy, Faculty of Medicine, Mental Health and Disease Department
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 Gender Dysphoria and Voice Disorder Due to Transsexualism, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 2 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: finished, as of the sponsor's last update on 8 Jul 2025. 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 Turkey (Türkiye). 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?
Change in Self-perception of voice (time frame: change from baseline to the 4th dose of hormone treatment). The study lists 3 primary outcomes in all. 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 8 Jul 2025.