ClinicalTrials.gg
Not yet recruitingNCT07817446H-TRANSUpdated Sep 14, 2026

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

An observational study in Headache and Migraine, sponsored by Chulalongkorn University. Not yet recruiting at 1 site in Thailand. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Chulalongkorn University · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Headache
  • Migraine

Keywords

  • Transgender Persons
  • Gender Diverse Persons
  • Gender-Affirming Hormone Therapy
  • Gender-Affirming Surgery
  • HIV Pre-Exposure Prophylaxis
  • Headache Prevalence
  • Migraine Prevalence
03

In context

Headache

762 studies on the registry are indexed under Headache; 134 are open to participants now.

This study's planned enrollment of 500 is above the median of 139 across 168 observational studies indexed under Headache.

Browse Headache studies →

Lead sponsor

Chulalongkorn University is the lead sponsor of 322 studies on the registry; 66 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The study population will consist of self-identified transgender adults in Thailand who currently attend or have previously attended the Tangerine Clinic at the Institute of HIV Research and Innovation in Bangkok, Thailand. Potential participants will be invited through online communication using contact information previously provided to the clinic or approached during a clinic visit. Interested individuals will access the study information, provide electronic informed consent, and complete the online questionnaire.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • Able to complete the online study questionnaire

Exclusion criteria

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
  • A medical condition known to cause a secondary headache disorder unrelated to migraine, such as head trauma, a structural brain lesion, or an infection
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • Transgender Adults

    Adults in Thailand who self-identify as transgender and currently attend or have previously attended the Tangerine Clinic in Bangkok. Participants will complete an online questionnaire about headache symptoms, migraine, gender-affirming care, and HIV pre-exposure prophylaxis use.

    Drug: gender-affirming hormone therapy · Procedure: Gender-Affirming Surgery · Drug: HIV Pre-Exposure Prophylaxis

Interventions

  • Druggender-affirming hormone therapy

    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.

  • ProcedureGender-Affirming Surgery

    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.

  • DrugHIV Pre-Exposure Prophylaxis

    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.

06

What researchers measure

Primary outcomes

  1. Prevalence of Headache

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

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

  2. Clinical Characteristics of Headache

    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.

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

Secondary outcomes

  1. Prevalence of Migraine

    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.

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

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

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

    Time frame: During the 3 months before enrollment

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

    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

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

  4. Association Between Gender-Affirming Surgery and Headache

    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

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

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

    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

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

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

    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

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

  7. Association Between Gender-Affirming Surgery and Migraine

    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

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

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

    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

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

07

Study locations

1 site
  • Location Back to Contacts and Locations On this page, enter a location where the study is taking place.
    Bangkok, 10330, Thailand
08

References and documents

Publications

  • Trovao Diniz E, Rocha Leite JB, Ribeiro Coutinho Madruga C, Maia Arca V, Macedo Cavalcanti Albuquerque JA, Sampaio Rocha-Filho PA. Headache in transgender men using gender-affirming hormone therapy: A case-control study. Headache. 2025 Sep;65(8):1449-1456. doi: 10.1111/head.14944. Epub 2025 Apr 18. PubMed 40251852 ↗
  • Zavala LJ, Gil Ramirez A, Vetvik KG, Jensen RH, Hougaard A. Headache in individuals undergoing hormone therapy for gender transition: A cross-sectional, observational study. Headache. 2026 Mar;66(3):725-732. doi: 10.1111/head.15076. Epub 2025 Oct 16. PubMed 41103036 ↗
  • Yalinay Dikmen P, Ertas M, Kosak S, Cimentepe C, Kocoglu M, Oztosun G, Direk Tecirli N, Onur Aysevener E. Primary headaches among gender dysphoric female-to-male individuals: A cross-sectional survey on gender transition experience. Headache. 2021 Sep;61(8):1194-1206. doi: 10.1111/head.14203. Epub 2021 Aug 31. PubMed 34463974 ↗
  • Hranilovich JA, Kaiser EA, Pace A, Barber M, Ziplow J. Headache in transgender and gender-diverse patients: A narrative review. Headache. 2021 Jul;61(7):1040-1050. doi: 10.1111/head.14171. PubMed 34363408 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07817446
Collaborators
Institute of HIV Research and Innovation Foundation, Thailand, International Headache Society
Responsible party
Sponsor
First posted
Sep 14, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Apr 1, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Sep 14, 2026

Study contacts

Prakit Anukoolwittaya, M.D.
Contact
Prakit.A@chula.ac.th
0629141942
Sirawit Roongrojwittayakul, M.D.
Contact
Prakit Anukoolwittaya, M.D.
principal investigator · Chulalongkorn University
Sirawit Roongrojwittayakul, M.D.
principal investigator · Ratchaburi Hospital
Akarin Hiransuthikul, M.D., M.Sc.
study director · Chulalongkorn University
Sekh Thanprasertsuk, M.D.
study director · Chulalongkorn University
Jakkrapatara Boonruang, M.D.
study director · Institute of HIV Research and Innovation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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