Effects of Gender-affirming Hormone Therapy on Transgender People

Sponsor
National Taiwan University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06022562
Collaborator
(none)
300
10

Study Details

Study Description

Brief Summary

This prospective cohort study aims to assess the impact of gender-affirming hormone therapy (GAHT) on transgender individuals' physical, psychological, social, and quality of life aspects. Based on gender minority stress theory, the research recruits 150 individuals each of those starting GAHT and those not yet undergoing it. Data collection involves questionnaires and physiological measurements. Statistical analyses will explore correlations and group differences. Findings can guide transgender individuals considering hormone therapy and enhance care guidelines to improve their overall well-being.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The willingness and proportion of transgender persons diagnosed with gender dysphoria to receive gender-affirming hormone therapy (GAHT) is relatively high, so as to conform to their internal gender identity. However, there are limited studies on the prospectively observation of the influences and effectiveness of GAHT on physical, psychological, social and quality of life of transgender people. This study is a cross-sectional research prospective cohort study design, and the research framework is developed based on gender minority stress theory. It is expected to recruit a group of 150 transgender people, including trans male, trans female, and non-binary person, who have just started using GAHT, and a group of 150 who has not yet received GAHT. The data collection time is about 40-50 minutes each time. The questionnaires will be applied to collect basic demographic information, basic hormonal information, body changes, body image, sexual wellbeing, sexual risk, depression, social support, and quality of life. The instruments will be applied to measure participants' physiological parameters, including weight, body fat, and muscle mass, hand grip strength, and blood pressure. In the statistical part, correlation and regression will be used to analyze the degree of correlation between variables, and multivariate analysis of covariance will be used to detect whether there was a significant difference between the variables of the two groups. A well understanding of the experiences and reactions of transgender people receiving hormone therapy can provide a reference for transgender people before deciding to accept hormone therapy, and can be used as an important reference for formulating care guidelines for gender-affirming hormone therapy to improve the care quality for the gender minority population.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Effects of Gender-affirming Hormone Therapy on the Psychosocial and Quality of Life of Transgender People: A Prospective Cohort Study
    Anticipated Study Start Date :
    Sep 30, 2023
    Anticipated Primary Completion Date :
    Jul 20, 2024
    Anticipated Study Completion Date :
    Jul 31, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    With gender-affirming hormone therapy

    With gender-affirming hormone therapy

    Without gender-affirming hormone therapy

    Without gender-affirming hormone therapy

    Outcome Measures

    Primary Outcome Measures

    1. Transgender Congruence Scale [1 year]

      Participants rated this 15 items scale on a 5-point Likert-type scale (i.e., 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree nor disagree, 4 = somewhat agree, 5 = strongly agree). Four of the 15 items were designed to be reverse-scored. Item responses were averaged, with higher scores indicating a higher level of congruence. So the maximum and minimum values of this scale are 75 and 15.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • transgender
    Exclusion Criteria:

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • National Taiwan University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Piao-Yi Chiou, Associate Professor, National Taiwan University
    ClinicalTrials.gov Identifier:
    NCT06022562
    Other Study ID Numbers:
    • 202302HM008
    First Posted:
    Sep 5, 2023
    Last Update Posted:
    Sep 5, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Piao-Yi Chiou, Associate Professor, National Taiwan University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 5, 2023