Swiss Prospective Cohort of TRansgender and Gender Diverse Individuals - SPECTRA-studien (SPECTRA)
26. juni 2026 oppdatert av: Bettina Winzeler, University Hospital, Basel, Switzerland
Målet med denne observasjonsstudien er å forstå faktorene som påvirker trivselen og helsen til transpersoner og kjønnsdiverse (TGD) individer som gjennomgår kjønnsbekreftende terapier i Sveits. Studiepopulasjonen inkluderer TGD-individer i alderen 16 år og eldre, på ulike stadier av deres medisinske overgang, inkludert de som har avbrutt eller gått over.
Hovedspørsmålet er:
Hva er nøkkelfaktorene som påvirker velvære og helseresultater til transpersoner og kjønnsforskjellige individer som gjennomgår kjønnsbekreftende terapier?
Forskere vil sammenligne helseutfall på tvers av ulike undergrupper, for eksempel de i ulike stadier av overgang eller detransisjon, for å undersøke effekten av kjønnsbekreftende terapier.
Deltakerne vil:
Fyll ut elektroniske spørreskjemaer som vurderer kjønnskongruens, livskvalitet, mental helse og andre utfall.
Gi biologiske prøver (f.eks. blod, urin, avføring og hudpinner) for laboratorieanalyse.
Gjennomgå kliniske evalueringer relatert til endokrinologi, fertilitet, dermatologi og urologi som en del av deres rutinemessige oppfølging.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Antatt)
600
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Hüseyin Cihan, Dr.
- E-post: hueseyin.cihan@usb.ch
Studer Kontakt Backup
- Navn: Bettina Winzeler, PD Dr.
- Telefonnummer: +41 61 556 50 75
- E-post: bettina.winzeler@usb.ch
Studiesteder
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Basel, Sveits, 4031
- Rekruttering
- University Hospital of Basel
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Ta kontakt med:
- Bettina Winzeler, PD Dr. med.
- Telefonnummer: +41 61 556 50 75
- E-post: bettina.winzeler@usb.ch
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Lucerne, Sveits, 6000
- Har ikke rekruttert ennå
- Cantonal Hospital of Lucerne
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Ta kontakt med:
- Lea Slahor, KD Dr.
- Telefonnummer: +41 205 51 03
- E-post: lea.slahor@luks.ch
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Zurich, Sveits, 8091
- Har ikke rekruttert ennå
- University Hospital of Zurich
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Ta kontakt med:
- Bettina Winzeler, PD Dr. med.
- Telefonnummer: +41 44 255 36 20
- E-post: bettina.winzeler@usb.ch
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Studiepopulasjonen for SPECTRA-studien vil bestå av transpersoner og kjønnsdiverse (TGD) individer i alderen 16 og oppover, diagnostisert med kjønnsinkongruens, og som mottar omsorg ved deltakende sveitsiske helsesentre.
Rekruttering vil starte ved Universitetssykehuset Basel og Lucerne Cantonal Hospital og utvides til andre sentre over hele Sveits.
Studien retter seg mot individer i ulike stadier av medisinsk overgang, inkludert de som starter, fortsetter eller avslutter kjønnsbekreftende terapier.
Innsatsen vil sikre inkludering av alle kjønnsidentiteter for å ivareta deres unike helsebehov på en helhetlig måte.
Beskrivelse
Inkluderingskriterier:
- Alder 16 år og oppover.
- Etablert diagnose av kjønnsinkongruens
- Indikasjon for kjønnsbekreftende terapi eller pågående eller seponert kjønnsbekreftende terapi
Ekskluderingskriterier:
- Kan ikke gi informert samtykke
- Manglende forpliktelse eller evne til å studere protokolloverholdelse
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Gender Congruence as Assessed by Gender Congruence and Life Satisfaction Scale (GCLS)
Tidsramme: 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 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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Gender identity
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Bettina Winzeler, PD Dr., University Hospital Basel, Department of Endocrinology
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
20. april 2026
Primær fullføring (Antatt)
1. januar 2046
Studiet fullført (Antatt)
1. januar 2046
Datoer for studieregistrering
Først innsendt
8. januar 2025
Først innsendt som oppfylte QC-kriteriene
8. januar 2025
Først lagt ut (Faktiske)
14. januar 2025
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
30. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2025-00514; kt24Winzeler
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .