Transgender PersonsTransRIHTSNCT04478760
Trans & Non-binary Reference Intervals While on Hormone Therapy Study
An observational study of Transgender Persons and Hormone Replacement Therapy, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
This study will find out what the reference intervals are for common blood tests in transgender people taking hormone therapy. Reference intervals help doctors interpret blood test results. They are expressed as two numbers, and most normal results fall between them. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Transgender Persons, Hormone Replacement Therapy, Reference Values
- How many people
- 250 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Apr 2021to 14 May 2024
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy transgender adults who have been taking masculinising for feminising hormone therapy for at least 12 months.
Who may be able to join
- Transgender or nonbinary people.
- Aged 18 or older.
- Taking testosterone or oestrogen therapy.
- For 12 months or more.
- Having routine hormone therapy monitoring at the clinic.
Who cannot join
- Unable to give informed consent (including participants who cannot communicate in English).
- History of chronic liver disease, chronic kidney disease, diabetes, or severe cardiovascular disease (including myocardial infection, deep vein thrombosis, stroke and pulmonary embolism).
- Blood test results that indicate severe disease.
- Pregnant or within one year after childbirth.
- Other conditions which could put participants at risk by participating, or which could influence the results of the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Caldecot Centre, King's College Hospital, 15-22 Caldecot Road
London, SE5 9RS
About this study
Official title: Reference Intervals for 27 Routine Chemistry and Immunoassay Tests in Transgender Adults on Stable Hormone Therapy
This study will find out what the reference intervals are for common blood tests in transgender people taking hormone therapy.
Reference intervals help doctors interpret blood test results. They are expressed as two numbers, and most normal results fall between them. If a results fall outside of them, it may be because of a disease. Some blood tests are also affected by normal difference between people, such as age, sex or ethnicity. For these tests, different reference intervals are given for each group of people. Having accurate reference intervals benefits patients because it allows doctors to identify disease faster.
Read more
Transgender people have a gender identity which does not match their sex characteristics at birth. Gender identity is the feeling of being a gender, and sex is the biological aspects of growing up male or female. Transgender people may use hormone therapy to help change their appearance to fit their gender identity. This involves taking either oestrogen or testosterone.
For blood tests which are affected by sex, it is not clear what reference intervals should be used for transgender people who are on hormone therapy. This is because they have a mixture of male and female sex characteristics. Answering this question will allow doctors to identify disease in them faster.
The study will take place at cliniQ, at King's College Hospital, which provides health services to transgender people. It will recruit healthy transgender people who attend the clinic for blood tests to monitor their hormone therapy. Participants will fill out a questionnaire, give a urine sample, then have their appointment as normal. Extra tests will also be performed on their blood sample. The aim is to recruit 240 participants. Participant's tests results will then be used to calculate reference intervals.
The study is funded by Viapath Group LLP.
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 |
|---|---|---|
| Masculinising therapy | Healthy transgender (including non-binary) adults who are on testosterone-containing hormone therapies. | |
| Feminising therapy | Healthy transgender (including non-binary) adults who are on oestrogen-containing hormone therapies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reference interval for transgender patients on hormone therapy
Establish reference intervals for routine chemistry and immunoassay test for transgender people on hormone therapy. Establish separate reference intervals for people on masculinising and feminising therapy if they differ substantially.
Measured: 1 day
Secondary outcomes (2)
Compare the reference intervals in patients taking different hormone therapy formulations.
Compare different hormone therapy formulations to establish whether there are clinically significant difference in their effects on reference intervals.
Measured: 1 day
Compare transgender reference intervals to the existing ones
Compare the reference values for transgender people on hormone therapy with the existing cisgender reference intervals to establish whether they are similar enough for the cisgender reference intervals to be used instead.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start13 Apr 2021
- Primary completion14 May 2024
- Study completion14 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transgender PersonsStudies 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Brady, FRCP, Principal investigator, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04478760
- Sponsor's protocol ID
- TransRIHTS Protocol
- Acronym
- TransRIHTS
- Status last verified
- Mar 2025
- First submitted
- 10 Jul 2020
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The full protocol, deidentified participant-level data and the analysis files will be uploaded to an open access repository within 6 months of the publication of the findings.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reference Intervals for 27 Routine Chemistry and Immunoassay Tests in Transgender Adults on Stable Hormone Therapy
- ClinicalTrials.gov ID
- NCT04478760
- Acronym / sponsor ID
- TransRIHTS / TransRIHTS Protocol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- 14 May 2024 (actual)
- Study completion
- 14 May 2024 (actual)
- First posted
- 21 Jul 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.
This study will find out what the reference intervals are for common blood tests in transgender people taking hormone therapy.
Reference intervals help doctors interpret blood test results. They are expressed as two numbers, and most normal results fall between them. If a results fall outside of them, it may be because of a disease. Some blood tests are also affected by normal difference between people, such as age, sex or ethnicity. For these tests, different reference intervals are given for each group of people. Having accurate reference intervals benefits patients because it allows doctors to identify disease faster.
Transgender people have a gender identity which does not match their sex characteristics at birth. Gender identity is the feeling of being a gender, and sex is the biological aspects of growing up male or female. Transgender people may use hormone therapy to help change their appearance to fit their gender identity. This involves taking either oestrogen or testosterone.
For blood tests which are affected by sex, it is not clear what reference intervals should be used for transgender people who are on hormone therapy. This is because they have a mixture of male and female sex characteristics. Answering this question will allow doctors to identify disease in them faster.
The study will take place at cliniQ, at King's College Hospital, which provides health services to transgender people. It will recruit healthy transgender people who attend the clinic for blood tests to monitor their hormone therapy. Participants will fill out a questionnaire, give a urine sample, then have their appointment as normal. Extra tests will also be performed on their blood sample. The aim is to recruit 240 participants. Participant's tests results will then be used to calculate reference intervals.
The study is funded by Viapath Group LLP.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Masculinising therapy | – | –Healthy transgender (including non-binary) adults who are on testosterone-containing hormone therapies. |
| Feminising therapy | – | –Healthy transgender (including non-binary) adults who are on oestrogen-containing hormone therapies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy transgender adults who have been taking masculinising for feminising hormone therapy for at least 12 months.
Key inclusion criteria (5 listed)
- Transgender or nonbinary people.
- Aged 18 or older.
- Taking testosterone or oestrogen therapy.
- For 12 months or more.
- Having routine hormone therapy monitoring at the clinic.
Key exclusion criteria (5 listed)
- Unable to give informed consent (including participants who cannot communicate in English).
- History of chronic liver disease, chronic kidney disease, diabetes, or severe cardiovascular disease (including myocardial infection, deep vein thrombosis, stroke and pulmonary embolism).
- Blood test results that indicate severe disease.
- Pregnant or within one year after childbirth.
- Other conditions which could put participants at risk by participating, or which could influence the results of the study.
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
Reference interval for transgender patients on hormone therapy
Time frame: 1 day
Establish reference intervals for routine chemistry and immunoassay test for transgender people on hormone therapy. Establish separate reference intervals for people on masculinising and feminising therapy if they differ substantially.
2 secondary outcomes
Compare the reference intervals in patients taking different hormone therapy formulations.
Time frame: 1 day
Compare transgender reference intervals to the existing ones
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Individual participant dataSharing planned: Yes. The full protocol, deidentified participant-level data and the analysis files will be uploaded to an open access repository within 6 months of the publication of the findings.
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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.
Michael Brady, FRCP principal investigator
King's College Hospital NHS Trust
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 Transgender Persons and Hormone Replacement Therapy, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 3 Sep 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reference interval for transgender patients on hormone therapy (time frame: 1 day). 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 3 Sep 2025.