Trans & Non-binary Reference Intervals While on Hormone Therapy Study

NCT04478760 | Completed

• 1 other identifier: TransRIHTS Protocol
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Transgender Persons; Hormone Replacement Therapy; Reference Values

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day

Secondary Outcomes (2)

• Compare the reference intervals in patients taking different hormone therapy formulations.

  1 day

• Compare transgender reference intervals to the existing ones

  1 day

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patients are eligible if they are transgender, that is, their gender is different from their sex assigned at birth.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy transgender adults who have been taking masculinising for feminising hormone therapy for at least 12 months.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Sites (1)

Caldecot Centre, King's College Hospital, 15-22 Caldecot Road

London, SE5 9RS, United Kingdom

Location

Study Officials

• Michael Brady, FRCP

  King's College Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 21, 2020
• Study Start: April 13, 2021
• Primary Completion: May 14, 2024
• Study Completion: May 14, 2024
• Last Updated: September 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Within 6 months of the publication of the results of the research.
• Access Criteria: Public access to deidentified data.

Locations

GB (1)