TransgenderNCT04440722
Prospective Observational Study and Biobank CKIO
An observational study of Transgender, run by Odense University Hospital at 1 site in Denmark.
Trial summary
Prospective observational study and biobank in all persons referred to CKIO Patient involvement and quality of life Population characteristics regarding hormone levels, safety parameters and clinical outcome before and after gender affirming hormone treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transgender
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2020to 1 Aug 2040
- Phase
- Observational
- Are there results?
- None posted in the registry
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 patients referred til CKIO
Who may be able to join
- All Individuals with gender dysforia who are referred to Center of Gender Identity Odense
- Age 18+
Who cannot join
- °There are no exclusion criteria
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Endocrinology, Odense University Hospital
Odense, 5000
About this study
Official title: Prospective Observational Study and Biobank in All Persons Referred to Center of Gender Identity Odense University Hospital (CKIO)/Body Identity Clinic
Prospective observational study and biobank in all persons referred to CKIO
- Patient involvement and quality of life
- Population characteristics regarding hormone levels, safety parameters and clinical outcome before and after gender affirming hormone treatment.
Read the detailed description
This is a prospective observational cohort study including all patients referred to the Center of Gender Identity Odense. The purpose is to follow patients yearly to observe patient reported outcomes and control the quality and effects of the clinical treatment.
- Conditions
- Transgender
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 |
|---|---|---|
| Transgender individuals | All transgender individuals referred to center of gender identity Odense |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported outcomes (PRO)
Questionnaires
Measured: Every 52 weeks
Hormone levels
Blood samples
Measured: Every 52 weeks
Safety parameters
Blood samples
Measured: Every 52 weeks
Secondary outcomes (6)
Blood pressure
Blood pressure measured in a sitting position
Measured: Every 52 weeks
Body mass index
Body mass index calculated from height an weight
Measured: Every 52 weeks
Body weight
Body weight measured on a scale in kilogram
Measured: Every 52 weeks
Hair cortisol
Hair samples 3 mm thick from the back of the head
Measured: Every 52 weeks
Cortisol metabolism
24 hour urine samples
Measured: Every 52 weeks
Spirometry
Forced vital capacity is measured by a spirometer
Measured: Every 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start1 Sep 2020
- Primary completion1 Aug 2040 (estimated)
- Study completion1 Aug 2040 (estimated)
Why it stopped: replaced by other study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TransgenderStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marianne Andersen, Odense University Hospital
- Investigators
- Marianne Andersen, Professor, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440722
- Sponsor's protocol ID
- BICTX02
- Status last verified
- Mar 2025
- First submitted
- 11 Jun 2020
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study and Biobank in All Persons Referred to Center of Gender Identity Odense University Hospital (CKIO)/Body Identity Clinic
- ClinicalTrials.gov ID
- NCT04440722
- Acronym / sponsor ID
- BICTX02
- Conditions
- Transgender
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: replaced by other study
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Aug 2040 (estimated)
- Study completion
- 1 Aug 2040 (estimated)
- First posted
- 22 Jun 2020 (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.
Prospective observational study and biobank in all persons referred to CKIO
- Patient involvement and quality of life
- Population characteristics regarding hormone levels, safety parameters and clinical outcome before and after gender affirming hormone treatment.
Detailed description
This is a prospective observational cohort study including all patients referred to the Center of Gender Identity Odense. The purpose is to follow patients yearly to observe patient reported outcomes and control the quality and effects of the clinical treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transgender individuals | – | –All transgender individuals referred to center of gender identity Odense |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients referred til CKIO
Key inclusion criteria (2 listed)
- All Individuals with gender dysforia who are referred to Center of Gender Identity Odense
- Age 18+
Key exclusion criteria (1 listed)
- °There are no exclusion criteria
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
Patient reported outcomes (PRO)
Time frame: Every 52 weeks
Questionnaires
Hormone levels
Time frame: Every 52 weeks
Blood samples
Safety parameters
Time frame: Every 52 weeks
Blood samples
6 secondary outcomes
Blood pressure
Time frame: Every 52 weeks
Body mass index
Time frame: Every 52 weeks
Body weight
Time frame: Every 52 weeks
Hair cortisol
Time frame: Every 52 weeks
Cortisol metabolism
Time frame: Every 52 weeks
Spirometry
Time frame: Every 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Marianne Andersen, Professor principal investigator
Odense University Hospital
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 Transgender, run by Odense University Hospital 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 2 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: paused, as of the sponsor's last update on 21 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient reported outcomes (PRO) (time frame: Every 52 weeks). The study lists 3 primary outcomes in all. 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 21 Mar 2025.