TransgenderismNCT04254354
Transgender Men, Non-binary Persons and Testosterone Treatment BODY IDENTITY CLINIC
An observational study of Transgenderism, run by Marianne Andersen at 1 site in Denmark.
Trial summary
The aim of this study is to investigate transgender men and non-binary persons before and during testosterone treatment. The study will focus on: Cardiovascular status Muscle strenght and power Aggression and quality of life Cardiac and respiratory function Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Transgenderism
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Mar 2020to 1 Jan 2044
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Persons assigned female at birth (+18 years) that either use or want to use testosterone with the purpose of undergoing gender transformation. -
Who may be able to join
- Transgender men
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
Odense University Hospital
Odense, 5000
Mariannne S Andersen, Prof, +4565412502, msa@rsyd.dk
About this study
Official title: Masculinizing Testosterone Treatment and Effects on Preclinical Cardiovascular Disease, Muscle Strength and Power, Aggression, Physical Fitness and Respiratory Function in Transgender Men,Body Identity Clinic (BIC)
The aim of this study is to investigate transgender men and non-binary persons before and during testosterone treatment. The study will focus on:
- Cardiovascular status
- Muscle strenght and power
- Aggression and quality of life
- Cardiac and respiratory function
Read the detailed description
Introduction: The number of individuals with gender dysphoria seeking gender-affirming treatment is increasing. The short- and long-term effects of masculinizing treatment with testosterone are debated as serum testosterone increase up to 20-fold compared to cisgender women. We hypothesize that, testosterone treatment is associated with non-calcified coronary plaque (NCP) development in transgender men.
Methods and analyses: Prospective, single-center, observational cohort study at the Body Identity Clinic (BIC), Odense University Hospital, Denmark, where all investigations are performed at inclusion and after 1, 3, 5 and 10 years of testosterone therapy.
Ethics and dissemination: The Regional Committees on Health Research Ethics for Southern Denmark (S-20190108) and the Danish Data Protection Agency approved the study (19/27572). Signed informed consent will be obtained from all participants. All findings will be published in peer-reviewed journals or at scientific conferences.
- Conditions
- Transgenderism
- Medical subject headings
- Transsexualism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| transgender men | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of testosterone on devellopment of plaques in the heart
Estimated directly by CCTA, at start, (1 year for early included participants) 5 and 10 years
Measured: 10 years
Secondary outcomes (12)
Calcium score
CCTA
Measured: 10 years
Change in muscle strength and power
Estimated by low row and accelometer at start, 1, 3, 5, 10 years
Measured: 10 years
Effect of transgender treatment on quality of life
Estimated by quality of life questionnaire (SF36) at start, 1, 3, 5 and 10 years
Measured: 10 years
Effect of transgender treatment on aggression
Estimated by aggression questionnaire at start, 1, 3, 5 and 10 years
Measured: 10 years
Changes in maximal oxygen consumption during transgender treatment
Estimated by test og maximal oxygen consumption (vo2max) at start, 1, 3, 5 and 10 years
Measured: 10 years
Heart function
Ejection fraction and left ventricular muscle mass are measured by echocardiography at start,(1 for early included participants) 5 and 10 years
Measured: 10 years
Respiratory function
Forced Expiratory Volume in the first second and forced vital capacity estimated by spirometry at start, 1, 3, 5 and 10 years
Measured: 10 years
Levels of testosterone, estradiol and cortisol
Measured in serum by LCMS/MS
Measured: 10 years
circulating markers of inflammation
CRP in blood samples
Measured: 10 years
circulating markers of cardiovascular risk
Lipids, SuPAR in blood samples
Measured: 10 years
Assessment of cortisol/cortisone
measured in urine and hair samples by LCMS/MS
Measured: 10 years
Change in lean body mass
Estimated by dual x-ray absorptiometry at start, 1, 3, 5 and 10 years
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start3 Mar 2020
- Primary completion1 Jan 2044 (estimated)
- Study completion1 Jan 2044 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TransgenderismStudies of the same condition, open and under way.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marianne Andersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marianne Andersen, Odense University Hospital
- Investigators
- Marianne Andersen, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04254354
- Sponsor's protocol ID
- BICTX01
- Status last verified
- Aug 2025
- First submitted
- 21 Jan 2020
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 42850896Lehmann Christensen L, Glintborg D, Taulbjerg Kristensen T, Diederichsen A, T'Sjoen G, Frystyk J, Skovsager Andersen M. Masculinising testosterone treatment and effects on preclinical cardiovascular disease, muscle strength and power, aggression, physical fitness and respiratory function in transgender men: protocol for a 10-year, prospective, observational cohort study in Denmark at the Body Identity Clinic (BIC). BMJ Open. 2020 Dec 29;10(12):e045714. doi: 10.1136/bmjopen-2020-045714.
PubMed 33376186
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Masculinizing Testosterone Treatment and Effects on Preclinical Cardiovascular Disease, Muscle Strength and Power, Aggression, Physical Fitness and Respiratory Function in Transgender Men,Body Identity Clinic (BIC)
- ClinicalTrials.gov ID
- NCT04254354
- Acronym / sponsor ID
- BICTX01
- Conditions
- Transgenderism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Marianne AndersenUniversity, hospital or other
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 1 Jan 2044 (estimated)
- Study completion
- 1 Jan 2044 (estimated)
- First posted
- 5 Feb 2020 (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.
The aim of this study is to investigate transgender men and non-binary persons before and during testosterone treatment. The study will focus on:
- Cardiovascular status
- Muscle strenght and power
- Aggression and quality of life
- Cardiac and respiratory function
Detailed description
Introduction: The number of individuals with gender dysphoria seeking gender-affirming treatment is increasing. The short- and long-term effects of masculinizing treatment with testosterone are debated as serum testosterone increase up to 20-fold compared to cisgender women. We hypothesize that, testosterone treatment is associated with non-calcified coronary plaque (NCP) development in transgender men.
Methods and analyses: Prospective, single-center, observational cohort study at the Body Identity Clinic (BIC), Odense University Hospital, Denmark, where all investigations are performed at inclusion and after 1, 3, 5 and 10 years of testosterone therapy.
Ethics and dissemination: The Regional Committees on Health Research Ethics for Southern Denmark (S-20190108) and the Danish Data Protection Agency approved the study (19/27572). Signed informed consent will be obtained from all participants. All findings will be published in peer-reviewed journals or at scientific conferences.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| transgender men | – | –no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Persons assigned female at birth (+18 years) that either use or want to use testosterone with the purpose of undergoing gender transformation. -
Key inclusion criteria (1 listed)
- Transgender men
Key exclusion criteria (1 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.
Primary outcome
Effect of testosterone on devellopment of plaques in the heart
Time frame: 10 years
Estimated directly by CCTA, at start, (1 year for early included participants) 5 and 10 years
12 secondary outcomes
Calcium score
Time frame: 10 years
Change in muscle strength and power
Time frame: 10 years
Effect of transgender treatment on quality of life
Time frame: 10 years
Effect of transgender treatment on aggression
Time frame: 10 years
Changes in maximal oxygen consumption during transgender treatment
Time frame: 10 years
Heart function
Time frame: 10 years
Respiratory function
Time frame: 10 years
Levels of testosterone, estradiol and cortisol
Time frame: 10 years
circulating markers of inflammation
Time frame: 10 years
circulating markers of cardiovascular risk
Time frame: 10 years
Assessment of cortisol/cortisone
Time frame: 10 years
Change in lean body mass
Time frame: 10 years
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 13 Aug 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.
- Derived from this study: PubMed 33376186Lehmann Christensen L, Glintborg D, Taulbjerg Kristensen T, Diederichsen A, T'Sjoen G, Frystyk J, Skovsager Andersen M. Masculinising testosterone treatment and effects on preclinical cardiovascular disease, muscle strength and power, aggression, physical fitness and respiratory function in transgender men: protocol for a 10-year, prospective, observational cohort study in Denmark at the Body Identity Clinic (BIC). BMJ Open. 2020 Dec 29;10(12):e045714. doi: 10.1136/bmjopen-2020-045714.
- Individual participant dataSharing planned: Undecided
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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.
Marianne Andersen 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 Marianne Andersen 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 1 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 13 Aug 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 marianne andersen, Professor (+4565412502, msa@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of testosterone on devellopment of plaques in the heart (time frame: 10 years). 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 NCT04254354, which also lists 2 linked publications.
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 13 Aug 2025.