Feminizing Treatment in Transgender Women and Non-binary... | NCT05169762

Studies
Feminizing Treatment in Transgender Women and Non-binary Persons

NCT05169762

Sponsor

Odense University Hospital

Status

Recruiting

Last Update Posted

Mar 21, 2025Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Transgenderism

Interventions

standard treatment

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2022Actual

Primary Completion Date

Sep 1, 2035Estimated

Completion Date

Sep 1, 2035Estimated

First Submitted Date

Sep 19, 2021

First Submission Date that Met QC Criteria

Dec 23, 2021

First Posted Date

Dec 27, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2025

Last Update Posted Date

Mar 21, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Cohort study in 100 transgender women treated with gender affirming hormone treatment. Follow up affter 1year, 3 years, 5 years and 10 years, Outcomes regarding cardiovascular effects of hormone treatment.

Detailed Description

Cohort study in 100 transgender women treated with gender affirming hormone treatment. Follow up affter 1year, 3 years, 5 years and 10 years,

Outcomes:

Non-calcified and calcified plaque formation by contras coronary CT angiograms Heartfunction by ekko Cardiovaskular risk markers, f. eks. bp Markers of cardiovascular risk in blood and urine

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
transgender women		transgender women eligeble to start gender affirming hormone treatment	Other: standard treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
standard treatment	Other	starndard treatment for transgender women	transgender women

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
coronary plaque formation	mm3	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

assigned male at birth and eligeble for gender affirming feminizing treatment

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

assigned male at birth, identifiing as transgender women

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

transgender women

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dorte Glintborg	Contact	+4565411807		dorte.glintborg@rsyd.dk

Overall Officials

Name	Affiliation	Role
Dorte Glintborg	Odense University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
OdenseUH	Recruiting	Odense		5230	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014189	Transsexualism

Ancestor Terms

ID	Term
D019529	Sexuality
D012725	Sexual Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided