A Trial to Compare Antibacterial vs. Placebo Mouthwash to Reduce the Incidence of Sexually Transmitted Infections (STIs) in Men Who Have Sex With Men (MSM) Taking HIV Pre-Exposure Prophylaxis (PrEP)

NCT03881007 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 343

Last updated 2021-05-07

Study results available
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Summary

The study involves a randomized placebo controlled trial that aims to assess if a mouthwash (Listerine cool mint, LCM) is able to reduce the cumulative incidence of gonorrhoea (Ng), chlamydia (Ct) and syphilis in men who have sex with men and receiving preexposure prophylaxis (PrEP) at the Institute of Tropical Medicine (ITM).

Conditions

  • Sexually Transmitted Diseases

Interventions

OTHER

Mouthwash with LCM

Subjects will mouthwash daily with LCM and before/after sex

OTHER

Mouthwash with placebo

Subjects will mouthwash daily with placebo and before/after sex

Sponsors & Collaborators

  • Institute of Tropical Medicine, Belgium

    lead OTHER

Principal Investigators

  • Chris Kenyon, MD · Institute of Tropical Medicine Antwerp

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-03
Primary Completion
2020-06-15
Completion
2020-06-15

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03881007 on ClinicalTrials.gov