Swiss Prospective Cohort of TRansgender and Gender Diverse Individuals - SPECTRA-studien (SPECTRA)
26 juni 2026 uppdaterad av: Bettina Winzeler, University Hospital, Basel, Switzerland
Målet med denna observationsstudie är att förstå de faktorer som påverkar välbefinnandet och hälsan hos transpersoner och individer med mångfald mellan könen (TGD) som genomgår könsbekräftande terapier i Schweiz. Studiepopulationen inkluderar TGD-individer i åldern 16 år och äldre, i olika stadier av sin medicinska övergång, inklusive de som har avbrutit eller avbrutit behandlingen.
Huvudfrågan är:
Vilka är nyckelfaktorerna som påverkar välbefinnandet och hälsoresultaten för transpersoner och individer med olika kön som genomgår könsbekräftande terapier?
Forskare kommer att jämföra hälsoresultat mellan olika undergrupper, såsom de i olika stadier av övergång eller detransition, för att undersöka effekterna av könsbejakande terapier.
Deltagarna kommer att:
Fyll i elektroniska frågeformulär som bedömer könskongruens, livskvalitet, psykisk hälsa och andra resultat.
Tillhandahåll biologiska prover (t.ex. blod, urin, avföring och hudprover) för laboratorieanalys.
Genomgå kliniska utvärderingar relaterade till endokrinologi, fertilitet, dermatologi och urologi som en del av deras rutinmässiga uppföljning.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Observationell
Inskrivning (Beräknad)
600
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Hüseyin Cihan, Dr.
- E-post: hueseyin.cihan@usb.ch
Studera Kontakt Backup
- Namn: Bettina Winzeler, PD Dr.
- Telefonnummer: +41 61 556 50 75
- E-post: bettina.winzeler@usb.ch
Studieorter
-
-
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Basel, Schweiz, 4031
- Rekrytering
- University Hospital of Basel
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Kontakt:
- Bettina Winzeler, PD Dr. med.
- Telefonnummer: +41 61 556 50 75
- E-post: bettina.winzeler@usb.ch
-
Lucerne, Schweiz, 6000
- Har inte rekryterat ännu
- Cantonal Hospital of Lucerne
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Kontakt:
- Lea Slahor, KD Dr.
- Telefonnummer: +41 205 51 03
- E-post: lea.slahor@luks.ch
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Zurich, Schweiz, 8091
- Har inte rekryterat ännu
- University Hospital of Zurich
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Kontakt:
- Bettina Winzeler, PD Dr. med.
- Telefonnummer: +41 44 255 36 20
- E-post: bettina.winzeler@usb.ch
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Studiepopulationen för SPECTRA-studien kommer att bestå av transpersoner och gender-diverse (TGD) individer i åldern 16 och uppåt, diagnostiserade med könsinkongruens, och som får vård på deltagande schweiziska vårdcentraler.
Rekryteringen kommer att börja vid universitetssjukhuset Basel och Lucerne Cantonal Hospital och expandera till andra centra över hela Schweiz.
Studien riktar sig till individer i olika stadier av medicinsk övergång, inklusive de som initierar, fortsätter eller avbryter könsbekräftande terapier.
Insatser kommer att säkerställa inkludering av alla könsidentiteter för att på ett heltäckande sätt tillgodose deras unika vårdbehov.
Beskrivning
Inklusionskriterier:
- Ålder 16 år och uppåt.
- Fastställd diagnos av könsinkongruens
- Indikation för könsbejakande terapi eller pågående eller avbruten könsbekräftande terapi
Uteslutningskriterier:
- Det går inte att ge informerat samtycke
- Saknar engagemang eller förmåga att studera efterlevnad av protokoll
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Gender Congruence as Assessed by Gender Congruence and Life Satisfaction Scale (GCLS)
Tidsram: 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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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Gender identity
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Bettina Winzeler, PD Dr., University Hospital Basel, Department of Endocrinology
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
20 april 2026
Primärt slutförande (Beräknad)
1 januari 2046
Avslutad studie (Beräknad)
1 januari 2046
Studieregistreringsdatum
Först inskickad
8 januari 2025
Först inskickad som uppfyllde QC-kriterierna
8 januari 2025
Första postat (Faktisk)
14 januari 2025
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
30 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2025-00514; kt24Winzeler
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .