Health TrialsbyHealthPanel

Transgender In Transition

ConditionGender Incongruence
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversitätsklinikum Hamburg-Eppendorf

About this trial

Prospective trial in gender dysphoric patients who undergo gender-affirming hormone therapy, aiming to investigate psychological, biological and behavioural consequences of hormonal therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

diagnosis of gender incongruence (ICD-11) or gender dysphoria (DSM-5)

written informed consent following adequate oral and written Information

before gender-affirming hormonal treatment

Disqualifiers

pregnancy or breast-feeding

Trial population

Individuals with gender incongruence undergoing gender-affirming hormone treatment

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Online surveys

    Diagnostic test

    Psychometric measures within 14 online surveys, which is one at each assessment point (before and 3, 6, 9, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120 months after hormonal therapy).

Treatment groups

750 Participants
are divided into 1 treatment group
Group A: Transgender patients1 intervention

Trial outcomes

Primary outcomes

1

Mini International Neuropsychiatric Interview (MINI; Lecrubier et al., 1997)

The Mini International Neuropsychiatric Interview (MINI; Lecrubier et al., 1997) is a short structured clinical interview which enables researchers to make diagnoses of psychiatric disorders according to DSM-IV or ICD-10 and was designed for epidemiological studies and multicenter clinical trials.

Time frame
10 years

Secondary outcomes

1

Alcohol Use Disorders Identification Test-Consumption (Audit C; Wade et al., 2014)

The Alcohol Use Disorders Identification Test-Consumption (Audit C; Wade et al., 2014) measures the consumption of alcohol in the past 12 months via a self-rating of 3 items. For the planned study, further equivalent versions for the consumption of nicotine and cannabis were adapted with 9 items covering consumption behaviour.

Time frame
10 years
2

Transgender Congruence Scale (TCS; Kozee et al., 2012)

The Transgender Congruence Scale (TCS; Kozee et al., 2012) measures gender congruence via self-rating through twelve items and two subscales (congruence with appearance \& acceptance of gender identity) within the past two weeks.

Time frame
10 years
3

Gender Congruence and Life Satisfaction Scale (GCLS; Jones et al., 2018)

The Gender Congruence and Life Satisfaction Scale (GCLS; Jones et al., 2018) measures gender congruence and life satisfaction via self-rating through 38 items and seven subscales (genitals, breast, other secondary sexual characteristics, recognition of gender role, physical and emotional intimacy, physiological function and life satisfaction) with a time frame of six months.

Time frame
10 years
4

Brief Symptom Inventory (BSI; Derogatis and Melisaratos, 1983)

The Brief Symptom Inventory (BSI; Derogatis and Melisaratos, 1983) measures psychiatric symptoms via self-rating with a total of 53 items in the areas of somatisation, compulsivity, insecurity in social contact, depression, anxiety, aggression, phobic fear, paranoid thinking and psychoticism. The inventory refers to a description of the symptoms within the past week.

Time frame
10 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitätsklinikum Hamburg-Eppendorf

Lead sponsor

Source ClinicalTrials.gov
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