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Набор скоро начнётся NCT05583058

Sex Hormone Overdose and Misuse in Chinese Transgender and Gender Non-conforming Population

— Наблюдательное Gender Incongruence Gender Dysphoria

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Hormone Overdose and Misuse.
Кому может быть актуально
Состояния в реестре: Gender Incongruence, Gender Dysphoria. Базовые параметры: от 12 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

Sex Hormone Overdose and Misuse in Chinese Transgender and Gender Non-conforming Population: a Mixed-methods Study

Обзор

The investigators propose to investigate the definition of hormone overdose and misuse (HODM) in Chinese transgender and gender nonconforming population (TGNCs), address the incidence of HODM in Chinese TGNC population, related factors and risks, identify the probable causes of HODM, and follow up HODM individuals to explore long-term effects. The research questions are: Q1 What is the definition and the criteria of HODM in Chinese TGNC population? Q2 What is the prevalence of HODM in Chinese TGNC population? Q3 What factors and risks are relevant to HODM? Q4 What are the causes? Q5 What are the long-term effects of HODM in Chinese TGNC population, compared to those who enroll in regular GAHT regimens? The investigators decide to employ a mixed-methods design to construct a full research framework on HODM. A prospective cohort study is a component of the study. The study can be divided into four stages to address research questions. Stage I will establish a precise definition and eligibility criteria of HODM through expert panel meeting and stakeholder engagement. Subsequently, a cross-sectional study will be conducted to evaluate the rate, subtypes, and related factors of HODM in Chinese TGNCs. In Stage III, semi-structured interviews and focus groups for TGNCs who are identified as HODM will be employed to investigate the causes, motivations and personal impact factors. This stage will be divided into two phases, Stage III-a before the cross-sectional study to provide a brief picture of HODM behaviors, and Stage III-b after the cross-sectional study to draw an overall pattern. Lastly, all participants of Stage II or III who would like to participate in our follow-up will be included in prospective cohorts to assess long-term effects. Among the stages, the cohort study is the subject of the registration. The investigators propose two cohorts in the study. Participants who are identified as HODM will be assigned to cohort 1 \[HODM cohort\], and those who are identified as regular GAHT use will be assigned to cohort 2 \[non-HODM cohort\]. Participants will be asked to report their gender-related and hormone use-related conditions, and mental health-related conditions at specific timepoints. The investigators will compare the HODM cohort to the non-HODM cohort to see if the overall incidence of adverse effects, gender-related, hormone-related, and mental health-related conditions differ in the cohorts.

Вмешательства

  • Другое Hormone Overdose and Misuse
    This is an observational study. Hormone Overdose and Misuse is an exposure.

Первичные конечные точки

  • Moderate-to-severe adverse events [Срок оценки: 24 months from the baseline assessment]
  • Moderate-to-severe adverse events [Срок оценки: 60 months from the baseline assessment]
Вторичные конечные точки (12)
  • GAHT attrition [Срок оценки: 24 months from the baseline assessment]
  • GAHT attrition [Срок оценки: 60 months from the baseline assessment]
  • Gender dysphoria [Срок оценки: 24 months from the baseline assessment]
  • Gender dysphoria [Срок оценки: 60 months from the baseline assessment]
  • Depression [Срок оценки: 12 months from the baseline assessment]
  • Depression [Срок оценки: 24 months from the baseline assessment]
  • Depression [Срок оценки: 36 months from the baseline assessment]
  • Depression [Срок оценки: 60 months from the baseline assessment]
  • Anxiety [Срок оценки: 12 months from the baseline assessment]
  • Anxiety [Срок оценки: 24 months from the baseline assessment]
  • Anxiety [Срок оценки: 36 months from the baseline assessment]
  • Anxiety [Срок оценки: 60 months from the baseline assessment]

Критерии участия

Критерии включения

  • Individuals with Chinese nationality (excluding Hong Kong SAR, Macau SAR, and Taiwan).
  • Aged over 12.
  • Identify themselves as TGNCs of any subtypes, including transgender female, transgender male, genderqueer, gender non-binary, crossdresser, or other subtypes.
  • have experienced at least one month of GAHT of any regimens and frequency in the last one year, or is taking hormones during the period of the study.
  • Hormones taken include androgen, estrogen, progesterone, anti-androgen, and anti-estrogen of any chemical structures, trade names, or regimens.

Критерии исключения

  • Individuals who undertake GAHT in the absence of self-consciousness due to mental disorders, or under external coercion/abuse.
  • Refuse to sign or unable to understand the informed consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • School of Medicine, Xiamen University — Xiamen

Идентификаторы

NCT: NCT05583058 · HODM-TGNC-C-01O

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗