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

NCT07817446 | Not Yet Recruiting

• 1 other identifier: Med Chula IRB 0840/69
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Headache; Migraine

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Prevalence of Headache

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

  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.

  At enrollment during the one-time online questionnaire

Secondary Outcomes (8)

• Prevalence of Migraine

  At enrollment during the one-time online questionnaire

• Headache-Related Disability Assessed Using the Migraine Disability Assessment Questionnaire

  During the 3 months before enrollment

• Association Between Gender-Affirming Hormone Therapy Use and Headache

  At enrollment during the one-time online questionnaire

• Association Between Gender-Affirming Surgery and Headache

  At enrollment during the one-time online questionnaire

• Association Between HIV Pre-Exposure Prophylaxis Use and Headache

  At enrollment during the one-time online questionnaire

Study Arms (1)

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

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.

Transgender Adults

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.

Transgender Adults

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.

Transgender Adults

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Individuals who self-identify as transgender, regardless of sex assigned at birth.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead
• Institute of HIV Research and Innovation Foundation, Thailand: collaborator
• International Headache Society: collaborator

Study Sites (1)

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

Bangkok, 10330, Thailand

Location

Related Publications (4)

• 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.

  PMID: 40251852 RESULT

• 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.

  PMID: 41103036 RESULT

• 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.

  PMID: 34463974 RESULT

• 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.

  PMID: 34363408 RESULT

MeSH Terms

Conditions

Headache; Migraine Disorders

Interventions

Gender-Affirming Surgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Gender-Affirming Procedures; Therapeutics; Plastic Surgery Procedures; Surgical Procedures, Operative; Urogenital Surgical Procedures; Gender-Affirming Care; Delivery of Health Care; Patient Care Management; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Prakit Anukoolwittaya, M.D.

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

• Sirawit Roongrojwittayakul, M.D.

  Ratchaburi Hospital

  PRINCIPAL INVESTIGATOR

• Akarin Hiransuthikul, M.D., M.Sc.

  Chulalongkorn University

  STUDY DIRECTOR

• Sekh Thanprasertsuk, M.D.

  Chulalongkorn University

  STUDY DIRECTOR

• Jakkrapatara Boonruang, M.D.

  Institute of HIV Research and Innovation

  STUDY DIRECTOR

Central Study Contacts

Prakit Anukoolwittaya, M.D.

CONTACT

0629141942; Prakit.A@chula.ac.th

Sirawit Roongrojwittayakul, M.D.

CONTACT

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 14, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 14, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)