Prospective Observational Study and Biobank CKIO

Transgender Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04440722
• Other study ID #: BICTX02
• Status: Suspended
• Start date: September 1, 2020
• Est. completion date: August 1, 2040

Study information

• Verified date: November 2022
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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 information / eligibility

• Status: Suspended
• Enrollment: 100
• Est. completion date: August 1, 2040
• Est. primary completion date: August 1, 2040
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All Individuals with gender dysforia who are referred to Center of Gender Identity Odense
• Age 18+ Exclusion Criteria: °There are no exclusion criteria

Related Conditions & MeSH terms

• Transgender

Locations

Country	Name	City	State
Denmark	Department of Endocrinology, Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient reported outcomes (PRO)	Questionnaires	Every 52 weeks
Primary	Hormone levels	Blood samples	Every 52 weeks
Primary	Safety parameters	Blood samples	Every 52 weeks
Secondary	Blood pressure	Blood pressure measured in a sitting position	Every 52 weeks
Secondary	Body mass index	Body mass index calculated from height an weight	Every 52 weeks
Secondary	Body weight	Body weight measured on a scale in kilogram	Every 52 weeks
Secondary	Hair cortisol	Hair samples 3 mm thick from the back of the head	Every 52 weeks
Secondary	Cortisol metabolism	24 hour urine samples	Every 52 weeks
Secondary	Spirometry	Forced vital capacity is measured by a spirometer	Every 52 weeks