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Completed

NCT Number: NCT05166083

Investigation of the Perceptual and Acoustic 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.

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Key information

Conditions

Gender Dysphoria Hormone Replacement Therapy Mental Disorders Sexual Dysfunctions, Psychological Transgender Persons Voice Disorder Due to Transsexualism

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Hacettepe University, Speech and Language Therapy

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Testosterone Hormon Therapy

Other

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

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Change in Acoustic Voice Characteristics

    Time frame: change from baseline to the 4th dose of hormone treatment

    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).

  2. Change in Acoustic Voice Characteristics

    Time frame: change from baseline to the 8th dose of hormone treatment

    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).

  3. Change in Acoustic Voice Characteristics

    Time frame: change from 4th to the 8th dose of hormone treatment

    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).

  4. Changes in the person's severity of depression

    Time frame: change from baseline to the 4th dose of hormone treatment

    • Beck depression inventory (BDI)

  5. Changes in the person's severity of depression

    Time frame: change from baseline to the 8th dose of hormone treatment

    • Beck depression inventory (BDI)

  6. Changes in the person's severity of depression

    Time frame: change from 4th to the 8th dose of hormone treatment

    • Beck depression inventory (BDI)

  7. Changes in the person's perception of support

    Time frame: change from baseline to the 4th dose of hormone treatment

    • Multidimensional Scale of Perceived Social Support.

  8. Changes in the person's perception of support

    Time frame: change from baseline to the 8th dose of hormone treatment

    • Multidimensional Scale of Perceived Social Support.

  9. Changes in the person's perception of support

    Time frame: change from 4th to the 8th dose of hormone treatment

    • Multidimensional Scale of Perceived Social Support.

  10. Changes in the person's anxiety level

    Time frame: change from baseline to the 4th dose of hormone treatment

    • State-trait anxiety Inventory

  11. Changes in the person's anxiety level

    Time frame: change from baseline to the 8th dose of hormone treatment

    • State-trait anxiety Inventory

  12. Changes in the person's anxiety level

    Time frame: change from 4th to the 8th dose of hormone treatment

    • State-trait anxiety Inventory

  13. Changes in the person's gender perception and gender transition process

    Time frame: change from baseline to the 4th dose of hormone treatment

    • 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.

  14. Changes in the person's gender perception and gender transition process

    Time frame: change from baseline to the 8th dose of hormone treatment

    • 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.

  15. Changes in the person's gender perception and gender transition process

    Time frame: change from 4th to the 8th dose of hormone treatment

    • 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.

  16. Changes in the person's body image perception

    Time frame: change from baseline to the 4th dose of hormone treatment

    -Body cathexis scale

  17. Changes in the person's body image perception

    Time frame: change from baseline to the 8th dose of hormone treatment

    -Body cathexis scale

  18. Changes in the person's body image perception

    Time frame: change from 4th to the 8th dose of hormone treatment

    -Body cathexis scale

  19. Change in testosterone level

    Time frame: change from baseline to the 4th dose of hormone treatment

    Testosterone level measurement

  20. Change in testosterone level

    Time frame: change from baseline to the 8th dose of hormone treatment

    Testosterone level measurement

  21. Change in testosterone level

    Time frame: change from 4th to the 8th dose of hormone treatment

    Testosterone level measurement

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Investigation of the Perceptual and Acoustic Characteristic of Voice in Trans Man

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Dec 21, 2021
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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