Prospective Observational Study and Biobank CKIO
- Conditions
- Transgender
- Registration Number
- NCT04440722
- Lead Sponsor
- Odense University Hospital
- 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.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 100
- All Individuals with gender dysforia who are referred to Center of Gender Identity Odense
- Age 18+
°There are no exclusion criteria
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hormone levels Every 52 weeks Blood samples
Patient reported outcomes (PRO) Every 52 weeks Questionnaires
Safety parameters Every 52 weeks Blood samples
- Secondary Outcome Measures
Name Time Method Body mass index Every 52 weeks Body mass index calculated from height an weight
Hair cortisol Every 52 weeks Hair samples 3 mm thick from the back of the head
Cortisol metabolism Every 52 weeks 24 hour urine samples
Blood pressure Every 52 weeks Blood pressure measured in a sitting position
Body weight Every 52 weeks Body weight measured on a scale in kilogram
Spirometry Every 52 weeks Forced vital capacity is measured by a spirometer
Trial Locations
- Locations (1)
Department of Endocrinology, Odense University Hospital
🇩🇰Odense, Denmark