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NCT Number: NCT07817446

Headache and Hormone Use Among Transgender Population in Thailand: A Cross-Sectional Online Study

The goal of this observational study is to learn how common headache and migraine are and to describe headache patterns among transgender adults in Thailand. The main questions it aims to answer are:

* How common are headache and migraine among transgender adults in Thailand? * What headache patterns and levels of headache-related disability do participants report? * Are gender-affirming hormone therapy, gender-affirming surgery, or HIV pre-exposure prophylaxis (PrEP) use related to headache or migraine?

About 500 transgender adults aged 18 years or older who currently attend or previously attended the Tangerine Clinic in Bangkok, Thailand, will take part.

Participants will:

* Provide consent online * Complete an online questionnaire about their general health and headache symptoms * Answer questions about gender-affirming hormone therapy, gender-affirming surgery, and PrEP use * Complete questionnaires that screen for migraine and measure how headaches affect daily activities

This study will not assign any treatment or change the participants' usual medical care.

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Key information

Conditions

Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Location Back to Contacts and Locations On this page, enter a location where the study is taking place.

Bangkok, 10330, Thailand

Location contact

Jakkrapatara Boonruang, MD

CONTACT

[email protected]

+66 2 160 5372

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older
  • Self-identifies as transgender
  • Currently attends or has previously attended the Tangerine Clinic in Bangkok, Thailand
  • Able to understand the study information and provide electronic informed consent
  • Able to complete the online study questionnaire

Exclusion criteria

  • Alcohol or drug use, or a medical condition that, in the investigator's judgment, could interfere with completion of the study procedures or the ability to provide informed consent
  • A medical condition known to cause a secondary headache disorder unrelated to migraine, such as head trauma, a structural brain lesion, or an infection

Treatment and study plan

gender-affirming hormone therapy

Drug

Current or previous use of gender-affirming hormone therapy as part of the participant's usual care. Information about medication name, dose, route, frequency, duration, and adherence will be collected through an online questionnaire. The researchers will not assign or modify hormone therapy.

Gender-Affirming Surgery

Procedure

History of gender-affirming surgery received as part of the participant's usual care. The type and date of surgery will be collected through an online questionnaire. No surgical procedure will be assigned or performed as part of this study.

HIV Pre-Exposure Prophylaxis

Drug

Current or previous use of HIV pre-exposure prophylaxis as part of the participant's usual care. Information about PrEP use will be collected through an online questionnaire. The researchers will not prescribe or modify PrEP as part of this study.

Primary outcomes

  1. Prevalence of Headache

    Time frame: At enrollment during the one-time online questionnaire

    Number and percentage of participants who report headache in 1 year based on the structured online headache questionnaire.

  2. Clinical Characteristics of Headache

    Time frame: At enrollment during the one-time online questionnaire

    Number and percentage of participants reporting headache characteristics, including headache location, pain quality, aggravation by physical activity, nausea or vomiting, sensitivity to light, sensitivity to sound, aura symptoms, and reported headache triggers.

Secondary outcomes

  1. Prevalence of Migraine

    Time frame: At enrollment during the one-time online questionnaire

    Number and percentage of participants who screen positive for migraine based on the ID Migraine and American Migraine Prevalence and Prevention/American Migraine Study questionnaires.

  2. Headache-Related Disability Assessed Using the Migraine Disability Assessment Questionnaire

    Time frame: During the 3 months before enrollment

    Headache-related disability measured using the total Migraine Disability Assessment (MIDAS) score. Higher scores indicate greater headache-related disability.

  3. Association Between Gender-Affirming Hormone Therapy Use and Headache

    Time frame: At enrollment during the one-time online questionnaire

    Association between current or previous gender-affirming hormone therapy (GAHT) use and the presence of headache, as assessed by a self-reported headache item in the study questionnaire. The association will be estimated using logistic regression and reported as an odds ratio with a 95% confidence interval.

    Unit of Measure: Odds ratio

  4. Association Between Gender-Affirming Surgery and Headache

    Time frame: At enrollment during the one-time online questionnaire

    Association between a history of gender-affirming surgery and the presence of headache, as assessed by a self-reported headache item in the study questionnaire. The association will be estimated using logistic regression and reported as an odds ratio with a 95% confidence interval.

    Unit of Measure: Odds ratio

  5. Association Between HIV Pre-Exposure Prophylaxis Use and Headache

    Time frame: At enrollment during the one-time online questionnaire

    Association between current or previous HIV pre-exposure prophylaxis (PrEP) use and the presence of headache, as assessed by a self-reported headache item in the study questionnaire. The association will be estimated using logistic regression and reported as an odds ratio with a 95% confidence interval.

    Unit of Measure: Odds ratio

  6. Association Between Gender-Affirming Hormone Therapy Use and Migraine

    Time frame: At enrollment during the one-time online questionnaire

    Association between current or previous gender-affirming hormone therapy (GAHT) use and the presence of migraine, assessed using the ID Migraine and American Migraine Prevalence and Prevention/American Migraine Study questionnaires.. The association will be estimated using logistic regression and reported as an odds ratio with a 95% confidence interval.

    Unit of Measure: Odds ratio

  7. Association Between Gender-Affirming Surgery and Migraine

    Time frame: At enrollment during the one-time online questionnaire

    Association between a history of gender-affirming surgery and the presence of migraine, as assessed by the ID Migraine and American Migraine Prevalence and Prevention/American Migraine Study questionnaires. The association will be estimated using logistic regression and reported as an odds ratio with a 95% confidence interval.

    Unit of Measure: Odds ratio

  8. Association Between HIV Pre-Exposure Prophylaxis Use and Migraine

    Time frame: Time Frame: At enrollment during the one-time online questionnaire

    Association between current or previous HIV pre-exposure prophylaxis (PrEP) use and the presence of migraine, as assessed by the ID Migraine and American Migraine Prevalence and Prevention/American Migraine Study questionnaires. The association will be estimated using logistic regression and reported as an odds ratio with a 95% confidence interval.

    Unit of Measure: Odds ratio

Study contacts

Contact information is provided by the study sponsor or research team.

Prakit Anukoolwittaya, M.D.

CONTACT

[email protected]

0629141942

Sirawit Roongrojwittayakul, M.D.

CONTACT

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Collaborators

  • Institute of HIV Research and Innovation Foundation, Thailand
  • International Headache Society

Registry information

Acronym: H-TRANS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 14, 2026
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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