BIC-Estrogen: Feminizing Treatment in Transgender Women and Non-binary Persons
Sponsor
Odense University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05169762
Collaborator
(none)
100
1
163
0.6
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Study Design
Study Type:
Observational
Anticipated Enrollment
:
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Feminizing Treatment in Transgender Women and Non-binary Persons BODY IDENTITY CLINIC - ESTROGEN
Anticipated Study Start Date
:
Feb 1, 2022
Anticipated Primary Completion Date
:
Sep 1, 2035
Anticipated Study Completion Date
:
Sep 1, 2035
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| transgender women transgender women eligeble to start gender affirming hormone treatment |
Other: standard treatment
starndard treatment for transgender women
|
Outcome Measures
Primary Outcome Measures
- coronary plaque formation [1 year]
mm3
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- assigned male at birth and eligeble for gender affirming feminizing treatment
Exclusion Criteria:
none
-
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | OdenseUH | Odense | Denmark | 5230 |
Sponsors and Collaborators
- Odense University Hospital
Investigators
- Principal Investigator: Dorte Glintborg, Odense University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Marianne Andersen,
Clinical professor,
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT05169762
Other Study ID Numbers:
- BICTX03
First Posted:
Dec 27, 2021
Last Update Posted:
Dec 27, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Marianne Andersen,
Clinical professor,
Odense University Hospital