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AzTrials

Transgender WomenNCT06116201

Influences of Long Term Hormone Therapy on Physical Fitness and Vascular Function in Transgender Women

A study testing Estradiol and Estradiol and Anti-Androgen in people with Transgender Women, run by Chulalongkorn University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Transgender women who transitioned from male to female by hormone therapy demonstrate similar physical fitness and vascular function to males or females. Read more about this study

Who is it for?
Ages 20 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Transgender Women
What is being tested?
Estradiol and Estradiol and Anti-Androgen
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteThailand
Study dates
15 Aug 2020to 31 Jul 2021
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 20 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Cisgender men group (Body mass index between 18.5-24.9 and NO NCDs).
  • Cisgender women group (Body mass index between 18.5-24.9, No pregnant, NO NCDs).
  • Transgender women with orchiectomy (Body mass index between 18.5-24.9, taking estradiol, testosterone level below 10 nmol/L, NO NCDs).
  • Transgender women without orchiectomy (Body mass index between 18.5-24.9, taking estradiol and anti-androgen, testosterone level below 10 nmol/L, NO NCDs).

Who cannot join

  • Participants had an injury during testing.

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Faculty of Sports Science, Chulalongkorn University

    Pathum Wan, Bangkok, 10330

Other trials in Thailand

About this study

Transgender women who transitioned from male to female by hormone therapy demonstrate similar physical fitness and vascular function to males or females.

Read the detailed description

This cross-sectional study was to compare physical fitness and vascular function between cisgender men, cisgender women, and transgender women.

Being tested
Estradiol, Estradiol and Anti-Androgen, No intervention
Keywords
Transgender women, Physical fitness, Vascular function, Hormone therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EstradiolOther

    Estradiol

  • Estradiol and Anti-AndrogenOther

    Estradiol and Anti-Androgen

  • No interventionOther

    No intervention

Study groups in NCT06116201
Study groupRoleWhat they receive
Transgender women with orchiectomyExperimentalTransgender women who took medication for sex transition form male to female via estradiol hormone therapy and orchiectomy surgery. They were recruited for measurement of all variables in the study to compare with another group.
Receives: Other: Estradiol
Transgender women without orchiectomyExperimentalTransgender women who took medication for sex transition form male to female via estradiol hormone and anti-androgen hormone therapy. They were recruited for measurement of all variables in the study to compare with another group.
Receives: Other: Estradiol and Anti-Androgen
Cisgender menSham comparatorCisgender men who lived in normal life were not used medication process for sex transition. They were recruited for measurement of all variables in the study to compare with another group.
Receives: Other: No intervention
Cisgender womenSham comparatorCisgender women who lived in normal life were not used medication process for sex transition. They were recruited for measurement of all variables in the study to compare with another group.
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Heart rate

    Heart rate will be measured with automated blood pressure device (CARESCAPE V100, GE Dinamap).

    Measured: Baseline

  2. Blood pressure

    Systolic blood pressure and diastolic blood pressure will be measured with automated blood pressure device (CARESCAPE V100, GE Dinamap). Mean arterial blood pressure was calculated from systolic blood pressure and diastolic blood pressure via mean arterial pressure formula.

    Measured: Baseline

  3. Body weight

    Body weight and height will be measured with automated body composition machine (ioi 353, Jawon medical).

    Measured: Baseline

  4. Height

    Height will be measured with automated body composition machine (ioi 353, Jawon medical).

    Measured: Baseline

  5. Resting metabolic rate

    Energy expenditure will be measured by canopy study protocol with stationary gas analyzer (VMAX, Encore 29 system).

    Measured: Baseline

  6. Vascular structure

    Intima-Media Thickness will be measured with ultrasonography equipment on carotid artery (EPIQ 5G, Phillips).

    Measured: Baseline

  7. Macro vascular function

    Macro vascular function will be measured by brachial artery flow-mediated dilatation protocol on brachial artery with ultrasonography equipment (EPIQ 5G, Phillips).

    Measured: Baseline

  8. Arterial stiffness

    Arterial stiffness will be measured with brachial-ankle pulse wave velocity (VP-1000 plus, omrom Healthcare).

    Measured: Baseline

  9. Micro vascular function

    Micro vascular function will be measured by post-occlusive hyperemia protocol of fingertip cutaneous blood flow with laser doppler flowmetry device (PeriFlux system 5000, Perimed).

    Measured: Baseline

  10. Muscle mass

    Muscle mass will be measured with dual energy x-ray absorptiometry (Prodigy-Pro, GE healthcaare).

    Measured: Baseline

  11. Fat mass

    Fat mass will be measured with dual energy x-ray absorptiometry (Prodigy-Pro, GE healthcaare).

    Measured: Baseline

  12. Bone mineral content

    Bone mineral content will be measured with dual energy x-ray absorptiometry (Prodigy-Pro, GE healthcaare).

    Measured: Baseline

  13. Bone mineral density

    Bone mineral density will be measured with dual energy x-ray absorptiometry (Prodigy-Pro, GE healthcaare).

    Measured: Baseline

  14. T-score of bone density

    T-score will be measured with dual energy x-ray absorptiometry (Prodigy-Pro, GE healthcaare). T-score was separated into 3 categories, 1 or higher of T-score that is the healthy bone, -1 to -2.5 of T-score that is osteopenia, and -2.5 or lower that is osteoporosis.

    Measured: Baseline

  15. Cardiorespiratory fitness

    Maximal oxygen consumption will be measured by Bruce protocol for treadmill test with stationary gas analyzer (VMAX, Encore 29 system).

    Measured: Baseline

  16. Muscle strength and muscle endurance

    Muscle strength and muscle endurance will be measured by concentric/concentric protocol with isokinetic machine (Biodex Multi-Joint System-Pro, Biodex).

    Measured: Baseline

  17. Flexibility

    Sit and reach test will be measured by sit and reach protocol with sit and reach box (Grandsport).

    Measured: Baseline

  18. Agility

    Agility will be measured by T-test protocol with timing gate device (SpeedLight Timing System, Swiftperformance).

    Measured: Baseline

  19. Balance

    Balance will be measured by balance error scoring system (BESS) protocol with postural sway detected machine (Biosway, Biodex).

    Measured: Baseline

  20. Coordination and reaction time

    Coordination and reaction time will be measured by eye-hand coordination protocol with light reacted device (FITLIGHT Trainer).

    Measured: Baseline

  21. Muscular power

    Muscular power will be measured by vertical jump with force plate detected machine (Ballistic Measurement System \& FT 700 Power Cage, Fitness Technology).

    Measured: Baseline

  22. Speed

    Speed will be measured by sprint test for 40 meters with timing gate device (SpeedLight Timing System, Swiftperformance).

    Measured: Baseline

  23. Anaerobic fitness

    Anaerobic fitness will be measured by Wingate test protocol with ergocycle (Monark 894e).

    Measured: Baseline

Secondary outcomes (2)

  1. Quality of life level

    Quality of life will level will be measured by World Health Organization Quality of Life Brief - Thai questionnaire. The scores of questionnaire were 130 points for maximum value and 26 points for minimum value. 3 levels in quality of life were less than 61 points for below normal range, 61-95 points for normal range, and more than 95 points for above normal range.

    Measured: Baseline

  2. Stress level

    Stress level will be measured by Suanprung Stress Test-20 questionnaire. The scores of questionnaire were 100 points for maximum value and 20 points for minimum value. 4 levels in stress less than 24 points for low stress range, 24-41 points for normal stress range, 42-61 points for high stress range, and more than 61 points for severe stress range.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2023
  2. Study start15 Aug 2020
  3. Primary completion30 Jun 2021
  4. Study completion31 Jul 2021

Resources

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
Screening
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06116201
Sponsor's protocol ID
SPSC-7
Status last verified
Nov 2023
First submitted
27 May 2021
Last updated
28 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Saitong A, Naeowong W, Suksom D, Tanaka H. Physical Fitness and Exercise Performance of Transgender Women. Med Sci Sports Exerc. 2025 Jan 1;57(1):134-143. doi: 10.1249/MSS.0000000000003536. Epub 2024 Aug 12.

    PubMed 39140786

Questions about this trial

What is this clinical trial studying?

A study testing Estradiol and Estradiol and Anti-Androgen in people with Transgender Women, run by Chulalongkorn University at 1 site in Thailand.

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 4 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: finished, as of the sponsor's last update on 28 Nov 2023. 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 Thailand. 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. Some participants in this study may receive a placebo. 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?

Heart rate (time frame: Baseline). The study lists 23 primary outcomes in all. 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 NCT06116201, 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 28 Nov 2023.

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