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

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.

Study Overview

• Status: Suspended
• Conditions: Transgender

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Department of Endocrinology, Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients referred til CKIO

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Transgender individuals; All transgender individuals referred to center of gender identity Odense

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported outcomes (PRO)	Questionnaires	Every 52 weeks
Hormone levels	Blood samples	Every 52 weeks
Safety parameters	Blood samples	Every 52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Blood pressure measured in a sitting position	Every 52 weeks
Body mass index	Body mass index calculated from height an weight	Every 52 weeks
Body weight	Body weight measured on a scale in kilogram	Every 52 weeks
Hair cortisol	Hair samples 3 mm thick from the back of the head	Every 52 weeks
Cortisol metabolism	24 hour urine samples	Every 52 weeks
Spirometry	Forced vital capacity is measured by a spirometer	Every 52 weeks

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Investigators: Principal Investigator: Marianne Andersen, Professor, Odense University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Estimated): August 1, 2040
• Study Completion (Estimated): August 1, 2040

Study Registration Dates

• First Submitted: June 11, 2020
• First Submitted That Met QC Criteria: June 18, 2020
• First Posted (Actual): June 22, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: BICTX02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No