NCT04440722

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.

Trial Health

53
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
173mo left

Started Sep 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
Sep 2020Aug 2040

First Submitted

Initial submission to the registry

June 11, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 22, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
19.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2040

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2040

Last Updated

March 21, 2025

Status Verified

March 1, 2025

Enrollment Period

19.9 years

First QC Date

June 11, 2020

Last Update Submit

March 18, 2025

Conditions

Transgender

Outcome Measures

Primary Outcomes (3)

  • Patient reported outcomes (PRO)

    Questionnaires

    Every 52 weeks

  • Hormone levels

    Blood samples

    Every 52 weeks

  • Safety parameters

    Blood samples

    Every 52 weeks

Secondary Outcomes (6)

  • Blood pressure

    Every 52 weeks

  • Body mass index

    Every 52 weeks

  • Body weight

    Every 52 weeks

  • Hair cortisol

    Every 52 weeks

  • Cortisol metabolism

    Every 52 weeks

  • +1 more secondary outcomes

Study Arms (1)

Transgender individuals

All transgender individuals referred to center of gender identity Odense

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients referred til CKIO

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology, Odense University Hospital

Odense, 5000, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood, urine, hair

Study Officials

  • Marianne Andersen, Professor

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultat, Dr Med, professor

Study Record Dates

First Submitted

June 11, 2020

First Posted

June 22, 2020

Study Start

September 1, 2020

Primary Completion (Estimated)

August 1, 2040

Study Completion (Estimated)

August 1, 2040

Last Updated

March 21, 2025

Record last verified: 2025-03

Locations

DK(1)