TransgenderismBIC-EstrogenNCT05169762
Feminizing Treatment in Transgender Women and Non-binary Persons
An observational study of Transgenderism, run by Odense University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Transgenderism
- What is being tested?
- standard treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2022to 1 Sep 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: transgender women
Who may be able to join
- assigned male at birth and eligeble for gender affirming feminizing treatment
Who cannot join
- none
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
OdenseUH
Odense, 5230
Marianne Andersen, DMSci
About this study
Official title: Feminizing Treatment in Transgender Women and Non-binary Persons BODY IDENTITY CLINIC - ESTROGEN
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.
Read the 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
- Conditions
- Transgenderism
- Being tested
- standard treatment
- Keywords
- gender affirming hormone treatment, estrogen, cardiovascular risk
- Medical subject headings
- Transsexualism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard treatmentOther
starndard treatment for transgender women
| Study group | Role | What they receive |
|---|---|---|
| transgender women | transgender women eligeble to start gender affirming hormone treatment Receives: Other: standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
coronary plaque formation
mm3
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2021
- Study start1 Feb 2022
- Primary completion1 Sep 2035 (estimated)
- Study completion1 Sep 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TransgenderismStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marianne Andersen, Odense University Hospital
- Investigators
- Dorte Glintborg, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05169762
- Sponsor's protocol ID
- BICTX03
- Acronym
- BIC-Estrogen
- Status last verified
- Mar 2025
- First submitted
- 19 Sep 2021
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Madsen EB, Christensen LL, Bach SR, Christiansen LS, Norlund MK, Kristensen TT, T'Sjoen G, Hermann AP, Palm CVB, Frystyk J, Andersen MS, Overgaard M, Glintborg D. Cardiometabolic Protein Profile Changes During Gender-Affirming Hormone Therapy: A Prospective Clinical Study. Clin Endocrinol (Oxf). 2026 Oct 8. doi: 10.1111/cen.70209. Online ahead of print.
PubMed 42850896
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feminizing Treatment in Transgender Women and Non-binary Persons BODY IDENTITY CLINIC - ESTROGEN
- ClinicalTrials.gov ID
- NCT05169762
- Acronym / sponsor ID
- BIC-Estrogen / BICTX03
- Conditions
- Transgenderism
- Keywords
- gender affirming hormone treatment, estrogen, cardiovascular risk
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Sep 2035 (estimated)
- Study completion
- 1 Sep 2035 (estimated)
- First posted
- 27 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| transgender women | – | Other: standard treatmenttransgender women eligeble to start gender affirming hormone treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- transgender women
Key inclusion criteria (1 listed)
- assigned male at birth and eligeble for gender affirming feminizing treatment
Key exclusion criteria (2 listed)
- none
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard treatmentstarndard treatment for transgender women | Other | transgender women |
Primary outcome
coronary plaque formation
Time frame: 1 year
mm3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Derived from this study: PubMed 42850896Madsen EB, Christensen LL, Bach SR, Christiansen LS, Norlund MK, Kristensen TT, T'Sjoen G, Hermann AP, Palm CVB, Frystyk J, Andersen MS, Overgaard M, Glintborg D. Cardiometabolic Protein Profile Changes During Gender-Affirming Hormone Therapy: A Prospective Clinical Study. Clin Endocrinol (Oxf). 2026 Oct 8. doi: 10.1111/cen.70209. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dorte Glintborg principal investigator
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transgenderism, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dorte Glintborg (+4565411807, dorte.glintborg@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
coronary plaque formation (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05169762, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.