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Recruiting

NCT Number: NCT07397403

The Efficacy of Doxycycline Post Exposure Prophylaxis for Preventing STIs Among MSM in Bangkok, Thailand.

The objective of this research is to evaluate the efficacy and safety of doxycycline in MSM for preventing sexually transmitted infections (gonorrhea, chlamydia, and syphilis) in Thailand

Participation in this study will last approximately 12 weeks and will include 2-3 clinic visits, along with 10-11 follow-up phone contacts over a period of 11 weeks.

Recruiting

Interested in participating?

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Key information

Age range

18 day–60 day

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Bangrak STIs Center

Sathorn, Bangkok, 10120, Thailand

Location status: Recruiting

Location contact

Kittipoom Chinhiran, MD

CONTACT

[email protected]

Rossaphorn Kittiyaowamarn, MD

CONTACT

[email protected]

+66814501066

Rossaphorn Kittiyoawamarn, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Biological male, aged not over 60 years

Thai nationality

Able to read, communicate, and understand the Thai language

Men who have sex with men (MSM), aged 18 years or older and not over 60 years

Having at least one of the following risk factors:

A history of condomless sex, or condom failure (breakage, leakage, or slippage), via any sexual route with at least two sexual partners within the past 3 months

A diagnosis of gonorrhea, chlamydia, or syphilis within the past 6 months

Current use of HIV pre-exposure prophylaxis (PrEP)

Willing and able to participate in study procedures (e.g., able to return to the clinic for scheduled testing for gonorrhea, chlamydia, and syphilis; able to complete doxycycline use records; and able to receive follow-up phone calls from the research team)

Willing and able to provide written informed consent to participate in the study

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Exclusion criteria

  • History of allergy to tetracycline-class antibiotics

Diagnosed with syphilis and not yet treated, or currently receiving treatment with benzathine penicillin G or doxycycline

Receipt of benzathine penicillin G within the past 12 weeks

Prior receipt of a gonorrhea vaccine

Current use of medications or products that may interact with doxycycline, including:

Vitamin A derivatives (e.g., isotretinoin, acitretin)

Antiepileptic drugs (e.g., phenytoin, carbamazepine, phenobarbital)

Immunosuppressive agents (e.g., methotrexate)

Medications for heart failure or cardiac arrhythmias (e.g., digoxin)

Anticoagulants (e.g., warfarin)

Use of oral or injectable medications that affect blood cells, such as anticancer drugs, chemotherapy, systemic corticosteroids, or targeted therapies

History of renal impairment (eGFR < 60 mL/min/1.73 m²) or hepatic impairment (AST or ALT > 3 times the upper limit of normal)

Uncontrolled or unstable underlying diseases, such as hematologic disorders, cancer, autoimmune diseases, or neurological disorders

Severe medical or psychiatric conditions that, in the investigator's judgment, may increase study-related risk or impair the participant's ability to provide informed consent

Alcohol dependence (inability to control alcohol consumption, withdrawal symptoms upon reduction or cessation, or continued use despite harm) or illicit drug dependence (regular, uncontrolled use) within the past 12 months prior to enrollment, which may affect doxycycline use for STI prevention

Previous participation in this study with prior randomization

Treatment and study plan

Doxycycline (200mg/day)

Drug

Doxycycline 200 mg single dose after unprotected sex within 24-72 hours

Primary outcomes

  1. To evaluate the efficacy of doxycycline in preventing sexually transmitted infections (gonorrhea, chlamydia, and syphilis) among men who have sex with men in Thailand.

    Time frame: 12 weeks

    Measure the proportion of participants who test positive by NAAT for gonorrhea or chlamydia at any anatomical site (genital, pharyngeal, or rectal), or who are diagnosed with syphilis during the study period.

Study contacts

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

Kittipoom Chinhiran, MD

CONTACT

[email protected]

+66863583077

Rossapnorn Kittiyaowamarn, MD

CONTACT

[email protected]

+66814501066

Sponsors and collaborators

Lead sponsor

Bangrak STIs Center

Other Gov

Collaborators

  • Mahidol University

Registry information

Official study title

The Efficacy of Doxycycline Post Exposure Prophylaxis for Preventing Sexually Transmitted Diseases (Gonorrhea, Chlamydia, Syphilis) Among Men Who Have Sex With Men in Bangkok, Thailand.

Acronym: ThaiDoxyPEP

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 9, 2026
Registry last updated
Feb 9, 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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