TransgenderismEvingeNCT04971447
Extracellular Vesicles and Endothelial Function in Transgender Subjects
A study testing gender affirming hormonal treatment in transgender men and gender affirming hormonal treatment in transgender women in people with Transgenderism, run by Central Hospital, Nancy, France.
Trial summary
Cardiovascular diseases are the leading cause of mortality. In women, the prevalence of cardiovascular diseases is lower and the presentation of coronary events often atypical. The lack of evidence is related in part to the methodology of studies not considering sex as an essential biological variable. Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- Transgenderism
- What is being tested?
- gender affirming hormonal treatment in transgender men and gender affirming hormonal treatment in transgender women
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- No sites listed yet
- Study dates
- Aug 2022to Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 49 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Trasgender subject demanding gender affirming hormonal therapy
Who cannot join
- Previous hormonal therapy
- Pregnancy
- Chronic disease
- Cancer
- Obesity
- Drug abuse
- Alcohol
- Tabac
About this study
Official title: Effects of Plasma Extracellular Vesicles on Endothelial Function in Transgender Subjects
Cardiovascular diseases are the leading cause of mortality. In women, the prevalence of cardiovascular diseases is lower and the presentation of coronary events often atypical. The lack of evidence is related in part to the methodology of studies not considering sex as an essential biological variable. Hormonal treatment is prescribed in transgender subjects to promote the development of sexual characteristics of the desired sex. Early cardiovascular effects of hormonal treatment have been reported in transgender men, while long-term mortality is higher in transgender women. The aim of this project is to study the effects of gender affirming hormonal treatment on arterial stiffness in young transgender subjects followed at the University Hospital of Nancy.
- Conditions
- Transgenderism
- Being tested
- gender affirming hormonal treatment in transgender men, gender affirming hormonal treatment in transgender women
- Keywords
- transgender persons, hormonal therapy
- Medical subject headings
- Transsexualism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gender affirming hormonal treatment in transgender menDrug
testosterone enanthate
gender affirming hormonal treatment in transgender womenDrug
GnRH agonists + estrogen
| Study group | Role | What they receive |
|---|---|---|
| Group: transgender men | Experimental | Not described Receives: Drug: gender affirming hormonal treatment in transgender men |
| Groupe: control cis-gender women | No intervention | Not described |
| Group: transgender women | Experimental | Not described Receives: Drug: gender affirming hormonal treatment in transgender women |
| Groupe: control cis-gender men | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
pulse wave velocity
measurement of arterial stiffness
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study startAug 2022 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971447
- Sponsor's protocol ID
- 21.03.30.69624
- Acronym
- Evinge
- Status last verified
- Jul 2021
- First submitted
- 12 Jul 2021
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Plasma Extracellular Vesicles on Endothelial Function in Transgender Subjects
- ClinicalTrials.gov ID
- NCT04971447
- Acronym / sponsor ID
- Evinge / 21.03.30.69624
- Conditions
- Transgenderism
- Keywords
- transgender persons, hormonal therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Aug 2022 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 21 Jul 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.
Cardiovascular diseases are the leading cause of mortality. In women, the prevalence of cardiovascular diseases is lower and the presentation of coronary events often atypical. The lack of evidence is related in part to the methodology of studies not considering sex as an essential biological variable. Hormonal treatment is prescribed in transgender subjects to promote the development of sexual characteristics of the desired sex. Early cardiovascular effects of hormonal treatment have been reported in transgender men, while long-term mortality is higher in transgender women. The aim of this project is to study the effects of gender affirming hormonal treatment on arterial stiffness in young transgender subjects followed at the University Hospital of Nancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group: transgender men | Experimental | Drug: gender affirming hormonal treatment in transgender men |
| Groupe: control cis-gender women | No intervention | – |
| Group: transgender women | Experimental | Drug: gender affirming hormonal treatment in transgender women |
| Groupe: control cis-gender men | No intervention | – |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Trasgender subject demanding gender affirming hormonal therapy
Key exclusion criteria (8 listed)
- Previous hormonal therapy
- Pregnancy
- Chronic disease
- Cancer
- Obesity
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 |
|---|---|---|
| gender affirming hormonal treatment in transgender mentestosterone enanthate | Drug | Group: transgender men |
| gender affirming hormonal treatment in transgender womenGnRH agonists + estrogen | Drug | Group: transgender women |
Primary outcome
pulse wave velocity
Time frame: 24 months
measurement of arterial stiffness
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing gender affirming hormonal treatment in transgender men and gender affirming hormonal treatment in transgender women in people with Transgenderism, run by Central Hospital, Nancy, France.
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 8 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: status not confirmed, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pulse wave velocity (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2022.