Gender IdentityKIKNCT06953908
The Copenhagen Gender Identity Cohort
An observational study of Gender Identity and Gender Dysphoria, Adult, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The goal of this observational study is to systematically collect data on adults seeking medical and surgical treatments for gender incongruence. This prospective, longitudinal cohort aims to generate insights into the safety, effectiveness, and overall satisfaction with current treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gender Identity, Gender Dysphoria, Adult, Gender Incongruence
- How many people
- 2,000 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2022to 31 Jan 2032
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All participants must be deemed eligible for assessment at The Center for Gender Identity in Copenhagen.
Who may be able to join
- All patients referred to The Center for Gender Identity in Copenhagen
Who cannot join
- Inability to read and understand Danish
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
The Center for Gender Identity
Copenhagen
Christina E Fonvig, Ph.D., 004535456854, kik.rigshospitalet@regionh.dk
Malene Hilden, MD, Ph.d.
About this study
The goal of this observational study is to systematically collect data on adults seeking medical and surgical treatments for gender incongruence. This prospective, longitudinal cohort aims to generate insights into the safety, effectiveness, and overall satisfaction with current treatments. Additionally, the study seeks to identify areas for improvement and support healthcare professionals in making informed decisions. Most importantly, it aims to enhance the quality of life for transgender and gender-diverse individuals by ensuring that the care they receive aligns with their needs and goals.
Participants will include patients seeking treatment at the Copenhagen Center for Gender Identity, Denmark. Data collection will be both clinician- and patient-reported. Participants will be asked to complete online surveys at baseline, after the assessment process, and annually if they initiate hormone therapy. The study will systematically gather information on gender identity and transition experiences, sociodemographics, self-medication, health status, self-reported quality of life, and treatment preferences. Additionally, detailed records of treatment courses and specific interventions will be collected from all involved healthcare providers across specialties.
Read more
The study will evaluate the effects of different treatment options, both in the short and long term. It will explore how quality of life is associated with gender identity, transition, sociodemographics, lifestyle, and health, as well as assess the medical impact of various treatments, including counseling, hormone therapy, and surgery. Furthermore, the study will investigate the prevalence of side effects and complications related to treatment, as well as factors influencing treatment discontinuation, including cases of detransition.
Finally, the project will focus on quality indicators such as waiting times and patient satisfaction, contributing to the ongoing development of high-quality, patient-centered care for transgender and gender-diverse individuals.
- Keywords
- Gender Identity, Gender Incongruence
- Medical subject headings
- Gender Dysphoria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults seeking help regarding gender incongruence | All patients referred to The Center of Gender Identity in Copenhagen (CGI), 18 years or older, seeking medical og surgical treatment for gender incongruence. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of quality of life
The study uses the WHOQOL-BREF to assesses quality of life (QOL). The repeated assessment provides a snapshot of quality of life, allowing for the exploration of associations with other factors. The WHOQOL-BREF is scored from 0-100, with higher values indicating increased quality of life.
Change from baseline in the four domains (Physical Helath, Psychological, Relationships, Environment) to the latest recorded yearly assessment recorded within the study period (10 years from 2022-2032)
Measured: Baseline and latest yearly assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start1 Feb 2022
- Primary completion31 Jan 2032 (estimated)
- Study completion31 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender IdentityStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Esmann Fonvig, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953908
- Sponsor's protocol ID
- 001
- Acronym
- KIK
- Status last verified
- Apr 2025
- First submitted
- 3 Apr 2025
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing of individual participant data (IPD) is in conflict with Danish GDPR regulations, as it involves the transfer of personal and potentially sensitive information, which is restricted under Danish data protection laws to safeguard individuals' privacy and ensure compliance with strict legal and ethical requirements.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Copenhagen Gender Identity Cohort
- ClinicalTrials.gov ID
- NCT06953908
- Acronym / sponsor ID
- KIK / 001
- Keywords
- Gender Identity, Gender Incongruence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Jan 2032 (estimated)
- Study completion
- 31 Jan 2032 (estimated)
- First posted
- 1 May 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 systematically collect data on adults seeking medical and surgical treatments for gender incongruence. This prospective, longitudinal cohort aims to generate insights into the safety, effectiveness, and overall satisfaction with current treatments. Additionally, the study seeks to identify areas for improvement and support healthcare professionals in making informed decisions. Most importantly, it aims to enhance the quality of life for transgender and gender-diverse individuals by ensuring that the care they receive aligns with their needs and goals.
Participants will include patients seeking treatment at the Copenhagen Center for Gender Identity, Denmark. Data collection will be both clinician- and patient-reported. Participants will be asked to complete online surveys at baseline, after the assessment process, and annually if they initiate hormone therapy. The study will systematically gather information on gender identity and transition experiences, sociodemographics, self-medication, health status, self-reported quality of life, and treatment preferences. Additionally, detailed records of treatment courses and specific interventions will be collected from all involved healthcare providers across specialties.
The study will evaluate the effects of different treatment options, both in the short and long term. It will explore how quality of life is associated with gender identity, transition, sociodemographics, lifestyle, and health, as well as assess the medical impact of various treatments, including counseling, hormone therapy, and surgery. Furthermore, the study will investigate the prevalence of side effects and complications related to treatment, as well as factors influencing treatment discontinuation, including cases of detransition.
Finally, the project will focus on quality indicators such as waiting times and patient satisfaction, contributing to the ongoing development of high-quality, patient-centered care for transgender and gender-diverse individuals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults seeking help regarding gender incongruence | – | –All patients referred to The Center of Gender Identity in Copenhagen (CGI), 18 years or older, seeking medical og surgical treatment for gender incongruence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All participants must be deemed eligible for assessment at The Center for Gender Identity in Copenhagen.
Key inclusion criteria (1 listed)
- All patients referred to The Center for Gender Identity in Copenhagen
Key exclusion criteria (1 listed)
- Inability to read and understand Danish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of quality of life
Time frame: Baseline and latest yearly assessment.
The study uses the WHOQOL-BREF to assesses quality of life (QOL). The repeated assessment provides a snapshot of quality of life, allowing for the exploration of associations with other factors. The WHOQOL-BREF is scored from 0-100, with higher values indicating increased quality of life. Change from baseline in the four domains (Physical Helath, Psychological, Relationships, Environment) to the latest recorded yearly assessment recorded within the study period (10 years from 2022-2032)
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 1 May 2025.
- Individual participant dataSharing planned: No. Sharing of individual participant data (IPD) is in conflict with Danish GDPR regulations, as it involves the transfer of personal and potentially sensitive information, which is restricted under Danish data protection laws to safeguard individuals' privacy and ensure compliance with strict legal and ethical requirements.
Related trials for Gender Identity
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Demographic Data Collection in Healthcare
Implementation Strategies
Enrolling by invitation
Efficacy of a Chronic Pain Treatment Prior to Gender-affirming Surgery
Pain Catastrophizing, Pain, Chronic
RecruitingObservational study
Comparative Study of Gender Identity Disorder Versus Control
Gender Dysphoria, Adult
RecruitingObservational study
Puberty, Testosterone, and Brain Development
Gender Identity, Gender Dysphoria in Adolescents and Adults
Active, not recruitingObservational study
Effect of Hormones on Frequency of Headache and Brain Structure and Function in Puberty
Headache, Gender Identity
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gender Identity and Gender Dysphoria, Adult, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 1 inclusion and 1 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 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of quality of life (time frame: Baseline and latest yearly assessment.). 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 1 May 2025.