Coorte Prospectiva Suíça de Transgêneros e Indivíduos Diversos de Gênero - o Estudo SPECTRA (SPECTRA)
26 de junho de 2026 atualizado por: Bettina Winzeler, University Hospital, Basel, Switzerland
O objetivo deste estudo observacional é compreender os fatores que influenciam o bem-estar e a saúde de indivíduos transgêneros e com diversidade de gênero (TGD) submetidos a terapias de afirmação de gênero na Suíça. A população do estudo inclui indivíduos TGD com 16 anos ou mais, em vários estágios de sua transição médica, incluindo aqueles que descontinuaram ou destransicionaram.
A questão principal é:
Quais são os principais factores que influenciam o bem-estar e os resultados de saúde de indivíduos transgénero e com diversidade de género submetidos a terapias de afirmação de género?
Os investigadores compararão os resultados de saúde em diferentes subgrupos, tais como aqueles em diferentes fases de transição ou destransição, para examinar os efeitos das terapias de afirmação de género.
Os participantes irão:
Preencha questionários eletrônicos avaliando congruência de gênero, qualidade de vida, saúde mental e outros resultados.
Forneça amostras biológicas (por exemplo, sangue, urina, fezes e esfregaços de pele) para análise laboratorial.
Submeter-se a avaliações clínicas relacionadas à endocrinologia, fertilidade, dermatologia e urologia como parte de seu acompanhamento de rotina.
Visão geral do estudo
Status
Recrutamento
Intervenção / Tratamento
Tipo de estudo
Observacional
Inscrição (Estimado)
600
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Hüseyin Cihan, Dr.
- E-mail: hueseyin.cihan@usb.ch
Estude backup de contato
- Nome: Bettina Winzeler, PD Dr.
- Número de telefone: +41 61 556 50 75
- E-mail: bettina.winzeler@usb.ch
Locais de estudo
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-
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Basel, Suíça, 4031
- Recrutamento
- University Hospital of Basel
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Contato:
- Bettina Winzeler, PD Dr. med.
- Número de telefone: +41 61 556 50 75
- E-mail: bettina.winzeler@usb.ch
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Lucerne, Suíça, 6000
- Ainda não está recrutando
- Cantonal Hospital of Lucerne
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Contato:
- Lea Slahor, KD Dr.
- Número de telefone: +41 205 51 03
- E-mail: lea.slahor@luks.ch
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Zurich, Suíça, 8091
- Ainda não está recrutando
- University Hospital of Zurich
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Contato:
- Bettina Winzeler, PD Dr. med.
- Número de telefone: +41 44 255 36 20
- E-mail: bettina.winzeler@usb.ch
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Método de amostragem
Amostra Não Probabilística
População do estudo
A população do estudo SPECTRA consistirá de indivíduos transgêneros e de gênero diversificado (TGD) com 16 anos ou mais, com diagnóstico de incongruência de gênero e recebendo cuidados nos centros de saúde suíços participantes.
O recrutamento começará no Hospital Universitário de Basileia e no Hospital Cantonal de Lucerna e se expandirá para outros centros em toda a Suíça.
O estudo tem como alvo indivíduos em vários estágios de transição médica, incluindo aqueles que iniciam, continuam ou descontinuam terapias de afirmação de gênero.
Os esforços assegurarão a inclusão de todas as identidades de género para abordar de forma abrangente as suas necessidades únicas de cuidados de saúde.
Descrição
Critérios de inclusão:
- Idade igual ou superior a 16 anos.
- Diagnóstico estabelecido de incongruência de gênero
- Indicação para terapia de afirmação de gênero ou terapia de afirmação de gênero em andamento ou descontinuada
Critérios de exclusão:
- Incapaz de dar consentimento informado
- Falta de compromisso ou capacidade de estudar a adesão ao protocolo
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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Group A: Cohort of Transgender and Gender Diverse individuals in Switzerland
Individuals who present before they start GAHT are included in group A
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The study program consists of assessments at baseline (before the start of GAHT) and subsequent follow-up visits scheduled at routine intervals which are typically every three months for the first year, every six months for the second year and every twelve months thereafter.
Participants' data collection includes a mix of digital and in-person methods.
Demographical information, clinical and laboratory parameters such as hormone levels which are part of standard clinical care
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Group B: Cohort of Transgender and Gender Diverse individuals in Switzerland
Individuals who are already on GAHT are included in group B
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The study program consists of a yearly assessment as part of the long-term routine follow-up.
Participants' data collection includes a mix of digital and in-person methods.
Demographical information, clinical and laboratory parameters such as hormone levels which are part of standard clinical care
|
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Group C: Cohort of Transgender and Gender Diverse individuals in Switzerland
Individuals who undergo gender affirming surgery are (additionally or exclusively) included in group C
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If GAS is administered, additional assessments are performed preoperatively, and postoperatively in analogy with routine clinical visits, e.g. one week after surgery and then three, six and twelve months later (then once yearly) (e.g.
type of surgery, outcome, patient' satisfaction).
If participants undergo gender-affirming genital surgery, a genital swab and urine analysis (from the urine sample taken for routine testing) will additionally be performed for microbiome analyses as part of the study assessment.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Gender Congruence as Assessed by Gender Congruence and Life Satisfaction Scale (GCLS)
Prazo: Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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The Gender Congruence and Life Satisfaction Scale (GCLS) is a validated outcome measure specifically developed for transgender individuals to assess distress and unhappiness with experienced gender and body, regardless of gender assigned at birth or gender identity.
The scale ranges from [insert range, e.g., 0-100], with higher scores indicating greater gender congruence and life satisfaction, and lower scores reflecting greater distress and unhappiness.
It is suitable for binary and nonbinary individuals seeking gender-affirming care.
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Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Gender identity
Prazo: Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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The gender identity is assessed using a study-specific questionnaire to determine the percentage of different gender identities (e.g.
binary, non-binary) and change of gender identity over time
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Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Difference in Gender Affirming Hormone Therapy (GAHT) regimens
Prazo: Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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The reported value will be the number and percentage of participants receiving each documented GAHT regimen category at each routine assessment, stratified by self-reported gender identity.
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Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Decision regret scale
Prazo: Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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The Decision Regret Scale is a validated tool that is used in this study to measure the regret after detransition.
The scale ranges from 0 to 100, with higher scores indicating greater regret and lower scores reflecting less or no regret.
It is widely applicable across different healthcare contexts to assess the emotional impact of decision-making.
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Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Body image states scale
Prazo: Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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The Body Image States Scale is a validated measure that is used in this study to assess an individual's momentary body image satisfaction after detransition.
The scale ranges from 0 to X, with higher scores indicating greater body image satisfaction and lower scores reflecting greater dissatisfaction.
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Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Quality of life score
Prazo: Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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The quality of life is meassured using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire.The EQ-5D-5L is a standardized measure, assessing mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
The scale provides a utility score ranging from 0 (equivalent to death) to 1 (perfect health), with higher scores indicating better health-related quality of life.
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Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Treatment Satisfaction Questionnaire for Medication 1.4
Prazo: Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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To evaluate treatment satisfaction an adapted Treatment Satisfaction Questionnaire for Medication 1.4 (TSQM-1.4) is used.
TSQM-1.4 is a validated tool, assessing patients' satisfaction with their treatments across four domains: effectiveness, side effects, convenience, and overall satisfaction.
The scale provides scores ranging from 0 to 100 for each domain, with higher scores indicating greater satisfaction.
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Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Beck Depression Inventory-II
Prazo: Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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The Beck Depression Inventory-II (BDI-II), a validated self-report measure, is used to assess depressive symptoms.
The scale ranges from 0 to 63, with higher scores indicating greater severity of depressive symptoms and lower scores reflecting minimal or no depression.
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Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Detransition rate
Prazo: Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Detransition is assessed as the percentage of individuals who interrupt or stop therapy over time.
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Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Reasons for stopping/reversing transition
Prazo: Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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The reasons for stopping/reversing transition is assessed using a questionnaire adapted from MacKinnon et al., 2024 (21 possible reasons for stopping/reversing transition).
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Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Gender Minority Stress and Resilience Measure
Prazo: Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
|
The Gender Minority Stress and Resilience Measure (GMSR) is a validated, assessing experiences of minority stress and resilience factors specific to transgender and gender-diverse individuals.
The scale includes multiple subscales with scores reflecting the levels of stress (e.g., discrimination, internalized transphobia) and resilience (e.g., community connectedness, pride).
Higher stress subscale scores indicate greater experiences of minority stress, while higher resilience subscale scores reflect stronger protective factors.
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Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Endocrine profiling
Prazo: Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Sex hormone are profiled on GAHT and in relation to the different outcome measures
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Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Blood pressure
Prazo: Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Blood pressure is taken (by unattended automated office blood pressure measurement =UAOBPM)
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Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Body mass index
Prazo: Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Body weight is measured and body mass index (BMI) calculated.
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Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Dietary Approaches to Stop Hypertension (DASH) score
Prazo: Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Dietary quality is assessed via Dietary Approaches to Stop Hypertension (DASH) scoring on a scale from 1-100, with higher score indicating healthier dietary habits.
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Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Mediterranean Eating Pattern (MEPA) score
Prazo: Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Dietary quality is assessed via Mediterranean Eating Pattern (MEPA) scoring on a scale from 1-100, with higher score indicating healthier dietary habits.
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Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Lipid profile
Prazo: Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Glucose homesostasis is assessed by measuring blood glucose, HOMA-Index, HbA1C.
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Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Inflammation hsCRP
Prazo: Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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hsCRP concentration measured in venous blood as part of routine laboratory assessment and reported as a continuous variable
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Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Inflammation IL-6
Prazo: Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Inflammatory markers are assessed including IL-6
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Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Health risk behaviors
Prazo: Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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National Health and Nutrition Examination Survey (NHANES) questionnaires assesses smoking, alcohol, physical activity.
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Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Sleep quality
Prazo: Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Pittsburgh Sleep Quality Index (PSQI) which ranges from 0 to 21.
Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties.
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Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Insomnia
Prazo: Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Insomnia Severity Index (ISI) is a self-assessment questionnaire ranging from 0-28, while higher score worse sleep quality
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Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Scalp hair cortisol concentration measured by liquid chromatography-tandem mass spectrometry
Prazo: Baseline and 12 months after initiation of GAHT
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Cortisol concentration measured in a proximal 3-cm scalp hair segment collected from the posterior vertex region
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Baseline and 12 months after initiation of GAHT
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Urinary steroid profile
Prazo: Baseline and 12 months after initiation of GAHT
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Steroid profile measured in a 24-hour urine sample to capture integrated steroid excretion over 24 hours.
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Baseline and 12 months after initiation of GAHT
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Immunological parameters cytokine levels
Prazo: Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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IL-6, TNF-α, IL-1β, IL-10 concentration measured in stored blood samples and reported as a continuous variable.
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Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Immunological parameters antibody levels
Prazo: Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Assessment of antibody levels
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Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Fertility Self-Assessment Responses Assessed Using a SPECTRA-Specific Questionnaire
Prazo: Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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The reported value will be the number and percentage of participants selecting each response category for prespecified fertility-related items, including fertility intentions, prior fertility preservation, interest in future fertility preservation, and fertility-related counseling needs, as assessed using a SPECTRA-specific self-assessment questionnaire.
This study-specific questionnaire is not summarized as a total score.
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Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Tucking practices
Prazo: Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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The reported value will be the number and percentage of participants who report current tucking practices on the SPECTRA questionnaire.
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Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Sexual Desire
Prazo: Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Sexual Desire Inventory (SDI).
The scores for the two dimensions of sexual desire are summed up separately.
Dyadic sexual desire: Scores will range from 0 to 62; while there is no universally established cutoff score that applies across all populations, higher scores at around 50 and upward indicate hypersexuality in the dyadic dimension.
Solitary sexual desire: Scores will range from 0 to 39; while there is no universally established cutoff score that applies across all populations, higher scores at around 31 and upward indicate hypersexuality in the solitary dimension.
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Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Semen Quality Status
Prazo: Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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The reported value will be the number and percentage of eligible participants in each predefined semen quality category at each assessment time point.
Semen quality status will be derived from standard semen analysis parameters according to prespecified laboratory criteria and categorized as normal semen quality, impaired semen quality, severe impairment, azoospermia, or not classifiable due to insufficient sample quality or missing parameters.
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Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Dermatology life quality index
Prazo: Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Dermatology life quality index (DLQI) is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.
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Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Visual analogue scale disease activity
Prazo: Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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disease activity is assessed by Visual analogue scale (VAS)
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Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Percentage of scalp hairs
Prazo: Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Percentage of hairs with reduced caliber assessed using TrichoScan software in a circular 1-cm² scalp area.
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Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Skin aging assessed by VISIA skin analysis
Prazo: Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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For the detection of skin wrinkles Visia device will be used as standardized photography
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Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Skin microbiome
Prazo: Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Skin swabs from defined sites to perform 16S rRNA amplicon based sequencing of the cutaneous bacterial microbiome
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Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Prosthesis outcome
Prazo: Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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In transmen, prosthesis outcome is assessed including complication rates, revision rates, survival rates, patient- and partner-related satisfaction rate e.g. with validated Questionnaire Quality of Life and Sexuality with Penile Prosthesis (QoLSPP)
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Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Urethral Complication Status Assessed by Clinical Examination
Prazo: Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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The reported value will be the number and percentage of eligible participants in each predefined urethral complication category at each assessment time point, as assessed by clinical examination and medical record review.
Categories will include no urethral complication, urethral stricture, urethral fistula, both urethral stricture and fistula, and other urethral complication.
For participants with urethral stricture or fistula, the type of management will be recorded descriptively according to predefined categories, including conservative management, catheter-based management, endoscopic treatment, surgical repair, or other management.
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Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Lower Urinary Tract Symptom Questionnaire
Prazo: Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Lower Urinary Tract Symptom Questionnaire is a self-assessment tool to grade lower urinary tract symptoms.
It ranges from 0-35, while typically a score of 0-7 indicates mild symptoms, 8-19 moderate symptoms and 20-35 severe symptoms.
Higher scores indicate more severe symptoms.
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Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Gut microbiome
Prazo: Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Alpha diversity, beta diversity, microbial richness and relative abundance diversity of the gut microbiome measured in stool samples and reported using a predefined diversity index.
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Baseline; 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, and 240 months
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Bettina Winzeler, PD Dr., University Hospital Basel, Department of Endocrinology
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
20 de abril de 2026
Conclusão Primária (Estimado)
1 de janeiro de 2046
Conclusão do estudo (Estimado)
1 de janeiro de 2046
Datas de inscrição no estudo
Enviado pela primeira vez
8 de janeiro de 2025
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de janeiro de 2025
Primeira postagem (Real)
14 de janeiro de 2025
Atualizações de registro de estudo
Última Atualização Postada (Real)
30 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
26 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2025-00514; kt24Winzeler
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .