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Prospective Observational Study and Biobank CKIO

Prospective Observational Study and Biobank in All Persons Referred to Center of Gender Identity Odense University Hospital (CKIO)/Body Identity Clinic

Status
Suspended
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04440722
Enrollment
100
Registered
2020-06-22
Start date
2020-09-01
Completion date
2040-08-01
Last updated
2025-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transgender

Brief 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.

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.

Interventions

None listed

Sponsors

Odense University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All Individuals with gender dysforia who are referred to Center of Gender Identity Odense * Age 18+

Exclusion criteria

°There are no

Design outcomes

Primary

MeasureTime frameDescription
Patient reported outcomes (PRO)Every 52 weeksQuestionnaires
Hormone levelsEvery 52 weeksBlood samples
Safety parametersEvery 52 weeksBlood samples

Secondary

MeasureTime frameDescription
Hair cortisolEvery 52 weeksHair samples 3 mm thick from the back of the head
Blood pressureEvery 52 weeksBlood pressure measured in a sitting position
SpirometryEvery 52 weeksForced vital capacity is measured by a spirometer
Cortisol metabolismEvery 52 weeks24 hour urine samples
Body mass indexEvery 52 weeksBody mass index calculated from height an weight
Body weightEvery 52 weeksBody weight measured on a scale in kilogram

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026