Effects of Gender-affirming Hormone Therapy on Transgender People

NCT06022562 | Completed

• 1 other identifier: 202302HM008
• Study Type: observational
• Target: 227
• Locations: 1 country
• Sites: 1

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.

Conditions

Gender Dysphoria

Keywords

depression; gender-affirming hormone therapy

Outcome Measures

Primary Outcomes (7)

• Transgender Congruence Scale

  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.

  1 year

• Gender Affirming Hormone Treatment Physical Symptoms Assessment Scale

  Participants rated this 17 items scale on a 4-point Likert-type scale. With higher scores indicates a higher level.

  1 year

• Sexual Risk Survey (SRS) Items

  Participants rated this 23 items. This questionnaire inquires about the frequency of subjects' experiences with each sexual risk. A higher frequency indicates a greater level of risk.

  1 year

• Short Sexual Well Being Scale

  Participants rated this 5 items scale on a 7-point Likert-type scale. With higher scores indicates a higher level.

  1 year

• Transgender individual Quality of Life

  Participants rated this 23 items scale on a 4-point Likert-type scale. With higher scores indicates a higher level.

  1 year

• Beck Depression Inventory-II

  The BDI-II, or Beck Depression Inventory-II, is a widely used self-report assessment tool for measuring the severity of depression. It consists of 21 multiple-choice questions or items. Of these 21 items, 13 are scored in the direction of increasing depression severity, while the remaining 8 are reverse-scored to assess positive attributes. The possible score range on the BDI-II is from 0 to 63, with higher scores indicating more severe depressive symptoms.

  1 year

• Multidimensional Perceived Social Support Scale

  The Multidimensional Perceived Social Support Scale (MPSSS) is a self-report questionnaire designed to assess an individual's perception of the level of social support they receive. It measures support from various sources, such as family, friends, and significant others, and evaluates different dimensions of support, including emotional, instrumental, and informational support. Participants rated this 13 items scale on a 4-point Likert-type scale with 4 different social related group. With higher scores indicates a higher level.

  1 year

Study Arms (2)

With gender-affirming hormone therapy

With gender-affirming hormone therapy

Without gender-affirming hormone therapy

Without gender-affirming hormone therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

transgender

You may qualify if:

• transgender

Sponsors & Collaborators

• National Taiwan University: lead

Study Sites (1)

National Taiwan University, College of Medicine, School of Nursing

Taipei, Taiwan

Location

MeSH Terms

Conditions

Gender Dysphoria; Depression

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, Psychological; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: September 5, 2023
• Study Start: January 8, 2024
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

TW (1)