HeadacheH-TRANSNCT07817446
Headache and Hormone Use Among Transgender Population in Thailand: A Cross-Sectional Online Study
An observational study of Headache and Migraine, run by Chulalongkorn University at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- gender-affirming hormone therapy, Gender-Affirming Surgery and HIV Pre-Exposure Prophylaxis
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteThailand
- Study dates
- 1 Nov 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sirawit Roongrojwittayakul, M.D. contact
Thailand1 site
Location Back to Contacts and Locations On this page, enter a location where the study is taking place.
Bangkok, 10330
Jakkrapatara Boonruang, MD, +66 2 160 5372, tangerineclinic@ihri.org
About this 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?
Read more
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.
- Being tested
- gender-affirming hormone therapy, Gender-Affirming Surgery, HIV Pre-Exposure Prophylaxis
- Keywords
- Transgender Persons, Gender Diverse Persons, Gender-Affirming Hormone Therapy, Gender-Affirming Surgery, HIV Pre-Exposure Prophylaxis, Headache Prevalence, Migraine Prevalence
- Medical subject headings
- Headache, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gender-affirming hormone therapyDrug
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 SurgeryProcedure or 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.
HIV Pre-Exposure ProphylaxisDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: gender-affirming hormone therapy; Procedure: Gender-Affirming Surgery; Drug: HIV Pre-Exposure Prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Headache
Number and percentage of participants who report headache in 1 year based on the structured online headache questionnaire.
Measured: At enrollment during the one-time online questionnaire
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.
Measured: At enrollment during the one-time online questionnaire
Secondary outcomes (8)
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.
Measured: At enrollment during the one-time online questionnaire
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.
Measured: During the 3 months before enrollment
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
Measured: At enrollment during the one-time online questionnaire
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
Measured: At enrollment during the one-time online questionnaire
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
Measured: At enrollment during the one-time online questionnaire
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
Measured: At enrollment during the one-time online questionnaire
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
Measured: At enrollment during the one-time online questionnaire
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
Measured: Time Frame: At enrollment during the one-time online questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HeadacheStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of HIV Research and Innovation Foundation, Thailand, International Headache Society
- Responsible party
- Sponsor
- Investigators
- Prakit Anukoolwittaya, M.D., Principal investigator, Chulalongkorn UniversitySirawit Roongrojwittayakul, M.D., Principal investigator, Ratchaburi HospitalAkarin Hiransuthikul, M.D., M.Sc., Study director, Chulalongkorn UniversitySekh Thanprasertsuk, M.D., Study director, Chulalongkorn UniversityJakkrapatara Boonruang, M.D., Study director, Institute of HIV Research and Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817446
- Sponsor's protocol ID
- Med Chula IRB 0840/69
- Acronym
- H-TRANS
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
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 40251852Zavala 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 41103036Yalinay 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 34463974Hranilovich 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Headache and Hormone Use Among Transgender Population in Thailand: A Cross-Sectional Online Study
- ClinicalTrials.gov ID
- NCT07817446
- Acronym / sponsor ID
- H-TRANS / Med Chula IRB 0840/69
- Keywords
- Transgender Persons, Gender Diverse Persons, Gender-Affirming Hormone Therapy, Gender-Affirming Surgery, HIV Pre-Exposure Prophylaxis, Headache Prevalence, Migraine Prevalence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Collaborators
- Institute of HIV Research and Innovation Foundation, Thailand, International Headache Society
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Sep 2026 (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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transgender Adults | – | Drug: gender-affirming hormone therapy, Procedure: Gender-Affirming Surgery, Drug: HIV Pre-Exposure ProphylaxisAdults 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gender-affirming hormone therapyCurrent 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. | Drug | Transgender Adults |
| Gender-Affirming SurgeryHistory 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. | Procedure or surgery | Transgender Adults |
| HIV Pre-Exposure ProphylaxisCurrent 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. | Drug | Transgender Adults |
Primary outcome
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.
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.
8 secondary outcomes
Prevalence of Migraine
Time frame: At enrollment during the one-time online questionnaire
Headache-Related Disability Assessed Using the Migraine Disability Assessment Questionnaire
Time frame: During the 3 months before enrollment
Association Between Gender-Affirming Hormone Therapy Use and Headache
Time frame: At enrollment during the one-time online questionnaire
Association Between Gender-Affirming Surgery and Headache
Time frame: At enrollment during the one-time online questionnaire
Association Between HIV Pre-Exposure Prophylaxis Use and Headache
Time frame: At enrollment during the one-time online questionnaire
Association Between Gender-Affirming Hormone Therapy Use and Migraine
Time frame: At enrollment during the one-time online questionnaire
Association Between Gender-Affirming Surgery and Migraine
Time frame: At enrollment during the one-time online questionnaire
Association Between HIV Pre-Exposure Prophylaxis Use and Migraine
Time frame: Time Frame: At enrollment during the one-time online questionnaire
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Results publication: PubMed 40251852Trovao 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.
- Results publication: PubMed 41103036Zavala 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.
- Results publication: PubMed 34463974Yalinay 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.
- Results publication: PubMed 34363408Hranilovich 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.
- Individual participant dataSharing planned: No
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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.
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
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 Headache and Migraine, 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 5 inclusion and 2 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: opening soon, as of the sponsor's last update on 14 Sep 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prakit Anukoolwittaya, M.D. (0629141942, Prakit.A@chula.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Headache (time frame: At enrollment during the one-time online questionnaire). The study lists 2 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 NCT07817446, which also lists 4 linked publications.
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 14 Sep 2026.