Transgender IndividualsSPECTRANCT06774053
Swiss ProspectivE Cohort of TRAnsgender and Gender Diverse Individuals - The SPECTRA Study
An observational study of Transgender Individuals and Gender Incongruence, run by University Hospital, Basel, Switzerland at 3 sites in Switzerland.
Trial summary
The goal of this observational study is to understand the factors influencing the well-being and health of transgender and gender-diverse (TGD) individuals undergoing gender-affirming therapies in Switzerland. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Transgender Individuals, Gender Incongruence
- What is being tested?
- Group A (start of GAHT), Group B (on-going GAHT) and Group C (GAS)
- How many people
- 600 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 20 Apr 2026to Jan 2046
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The project population will consist of TGD individuals above age 16 who are diagnosed with gender incongruence and who wish medical transition or are on medical transition (at any stage of their transition, including individuals who interrupt/-ed medical transition or detransition/-ed). Recruitment for the study will initially take place at the University Hospital of Basel and the Cantonal Hospital of Luzern, with plans to expand to additional centers (e.g. University Hospital of Zurich, University Hospital of Geneva and Cantonal Hospital of St Gallen) as the study progresses. The study targets individuals at various stages of medical transition, including those initiating, continuing, or discontinuing gender-affirming therapies. Efforts will ensure inclusion of all gender identities to comprehensively address their unique healthcare needs.
Who may be able to join
- Age 16 years and above.
- Established diagnosis of gender incongruence
- Indication for gender affirming therapy or ongoing or discontinued gender affirming therapy
Who cannot join
- Unable to give informed consent
- Missing commitment or ability to study protocol adherence
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hüseyin Cihan, Dr. contact
Switzerland3 sites, 3 recruiting
- Recruiting
University Hospital of Basel
Basel, 4031
Bettina Winzeler, PD Dr. med., +41 61 556 50 75, bettina.winzeler@usb.ch
- Not yet recruiting
Cantonal Hospital of Lucerne
Lucerne, 6000
Lea Slahor, KD Dr., +41 205 51 03, lea.slahor@luks.ch
- Not yet recruiting
University Hospital of Zürich
Zurich, 8091
Bettina Winzeler, PD Dr. med., +41 44 255 36 20, bettina.winzeler@usb.ch
About this study
Official title: Swiss Prospective Cohort of TRAnsgender and Gender Diverse Individuals - The SPECTRA Study
The goal of this observational study is to understand the factors influencing the well-being and health of transgender and gender-diverse (TGD) individuals undergoing gender-affirming therapies in Switzerland. The study population includes TGD individuals aged 16 and older, at various stages of their medical transition, including those who have discontinued or detransitioned.
The main question is:
Read more
What are the key factors influencing the well-being and health outcomes of transgender and gender-diverse individuals undergoing gender-affirming therapies?
Researchers will compare health outcomes across different subgroups, such as those at different stages of transition or detransition, to examine the effects of gender-affirming therapies.
Participants will:
Complete electronic questionnaires assessing gender congruence, quality of life, mental health, and other outcomes.
Provide biological samples (e.g., blood, urine, stool, and skin swabs) for laboratory analysis.
Undergo clinical evaluations related to endocrinology, fertility, dermatology, and urology as part of their routine follow-up.
- Conditions
- Transgender Individuals, Gender Incongruence
- Being tested
- Group A (start of GAHT), Group B (on-going GAHT), Group C (GAS)
- Keywords
- Gender Affirming Hormone Therapy (GAHT), Gender Affirming Surgery (GAS), Transgender and Gender Diverse (TGD)
- Medical subject headings
- Gender Dysphoria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A (start of GAHT)Other
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
Group B (on-going GAHT)Other
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
Group C (GAS)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Cohort of Transgender and Gender Diverse individuals in Switzerland | Individuals who present before they start GAHT are included in group A Receives: Other: Group A (start of GAHT) | |
| Group B: Cohort of Transgender and Gender Diverse individuals in Switzerland | Individuals who are already on GAHT are included in group B Receives: Other: Group B (on-going GAHT) | |
| 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 Receives: Other: Group C (GAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gender Congruence as Assessed by Gender Congruence and Life Satisfaction Scale (GCLS)
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start20 Apr 2026
- Primary completionJan 2046 (estimated)
- Study completionJan 2046 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transgender IndividualsStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Zürich, Cantonal Hospital Lucerne, Switzerland
- Responsible party
- Principal investigator, Bettina Winzeler, University Hospital, Basel, Switzerland
- Investigators
- Bettina Winzeler, PD Dr., Principal investigator, University Hospital Basel, Department of Endocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774053
- Sponsor's protocol ID
- 2025-00514; kt24Winzeler
- Other IDs
- 2025
- Acronym
- SPECTRA
- Status last verified
- Jun 2026
- First submitted
- 8 Jan 2025
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swiss Prospective Cohort of TRAnsgender and Gender Diverse Individuals - The SPECTRA Study
- ClinicalTrials.gov ID
- NCT06774053
- Acronym / sponsor ID
- SPECTRA / 2025-00514; kt24Winzeler
- Conditions
- Transgender Individuals, Gender Incongruence
- Keywords
- Gender Affirming Hormone Therapy (GAHT), Gender Affirming Surgery (GAS), Transgender and Gender Diverse (TGD)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- University Hospital, Zürich, Cantonal Hospital Lucerne, Switzerland
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- Jan 2046 (estimated)
- Study completion
- Jan 2046 (estimated)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to understand the factors influencing the well-being and health of transgender and gender-diverse (TGD) individuals undergoing gender-affirming therapies in Switzerland. The study population includes TGD individuals aged 16 and older, at various stages of their medical transition, including those who have discontinued or detransitioned.
The main question is:
What are the key factors influencing the well-being and health outcomes of transgender and gender-diverse individuals undergoing gender-affirming therapies?
Researchers will compare health outcomes across different subgroups, such as those at different stages of transition or detransition, to examine the effects of gender-affirming therapies.
Participants will:
Complete electronic questionnaires assessing gender congruence, quality of life, mental health, and other outcomes.
Provide biological samples (e.g., blood, urine, stool, and skin swabs) for laboratory analysis.
Undergo clinical evaluations related to endocrinology, fertility, dermatology, and urology as part of their routine follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: Cohort of Transgender and Gender Diverse individuals in Switzerland | – | Other: Group A (start of GAHT)Individuals who present before they start GAHT are included in group A |
| Group B: Cohort of Transgender and Gender Diverse individuals in Switzerland | – | Other: Group B (on-going GAHT)Individuals who are already on GAHT are included in group B |
| Group C: Cohort of Transgender and Gender Diverse individuals in Switzerland | – | Other: Group C (GAS)Individuals who undergo gender affirming surgery are (additionally or exclusively) included in group C |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The project population will consist of TGD individuals above age 16 who are diagnosed with gender incongruence and who wish medical transition or are on medical transition (at any stage of their transition, including individuals who interrupt/-ed medical transition or detransition/-ed). Recruitment for the study will initially take place at the University Hospital of Basel and the Cantonal Hospital of Luzern, with plans to expand to additional centers (e.g. University Hospital of Zurich, University Hospital of Geneva and Cantonal Hospital of St Gallen) as the study progresses. The study targets individuals at various stages of medical transition, including those initiating, continuing, or discontinuing gender-affirming therapies. Efforts will ensure inclusion of all gender identities to comprehensively address their unique healthcare needs.
Key inclusion criteria (3 listed)
- Age 16 years and above.
- Established diagnosis of gender incongruence
- Indication for gender affirming therapy or ongoing or discontinued gender affirming therapy
Key exclusion criteria (2 listed)
- Unable to give informed consent
- Missing commitment or ability to study protocol adherence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group A (start of GAHT)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 | Other | Group A: Cohort of Transgender and Gender Diverse individuals in Switzerland |
| Group B (on-going GAHT)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 | Other | Group B: Cohort of Transgender and Gender Diverse individuals in Switzerland |
| Group C (GAS)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. | Other | Group C: Cohort of Transgender and Gender Diverse individuals in Switzerland |
Primary outcome
Gender Congruence as Assessed by Gender Congruence and Life Satisfaction Scale (GCLS)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
Related trials for Transgender Individuals
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Kidney Disease, Kidney Injury
Not yet recruitingObservational study
Effects of Gender-Affirming Hormone Therapy on Cardiovascular, Metabolic, and Mental Health Outcomes in Transgender Adults.
Transgender Individuals
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hüseyin Cihan, Dr. contact
Bettina Winzeler, PD Dr. principal investigator
University Hospital Basel, Department of Endocrinology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transgender Individuals and Gender Incongruence, run by University Hospital, Basel, Switzerland at 3 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bettina Winzeler, PD Dr. (+41 61 556 50 75, bettina.winzeler@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gender Congruence as Assessed by Gender Congruence and Life Satisfaction Scale (GCLS) (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.