GonorrheaPhase 2NCT04966507
Antibacterial Mouthwash for Pharyngeal Gonorrhea Prevention
A Phase 2 study testing Listerine Antiseptic Mouthwash Product and Biotene Mouthwash in people with Gonorrhea, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This study aims to determine acceptability and preliminary efficacy of daily use of an antibacterial mouthwash as compared to a placebo mouthwash in reducing the incidence of pharyngeal gonorrhea among a cohort of HIV-positive and high risk HIV-negative men. Investigators plan to test the following hypotheses: 1. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Gonorrhea
- What is being tested?
- Listerine Antiseptic Mouthwash Product and Biotene Mouthwash
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2022to 12 Dec 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 45 years
- Men only
- No healthy volunteers
- Adult
This study will only include participants recruited as part an NIH/NIDA funded study (U01 DA036267 PIs Gorbach and Shoptaw) - the mSTUDY. By design, half of the participants are HIV-positive and half are HIV-negative and other inclusion criteria for the mSTUDY are as follows:
- At least 18 but not older than 45 years of age on day of consent
- Identified biologically male at birth
- Willing to return for follow-up study visits every 6 months as long as the study is ongoing and be available to return for all study visits, barring unforeseen circumstances
- Willing and able to provide written informed consent to take part in the study
- Willing and able to provide adequate information for locator purposes
- STI testing at each study visit (with reporting and treatment referral when indicated)
- Understands and agrees to local STI reporting requirements
- If HIV-negative at screening, report unprotected anal intercourse with a male in the past 6 months Additional inclusion criteria specific to this study are:
- Currently enrolled in mSTUDY
- mSTUDY participants who have turned 45 since enrollment in mSTUDY continue to be eligible for inclusion in this study.
- Previously diagnosed with pharyngeal gonorrhea (while an mSTUDY participant)
Participants will be excluded from the study if:
- Mouthwash use is contraindicated, for example because of allergies or those who may need to avoid the high alcohol content of mouthwash such as recovery alcoholics maintaining their sobriety
- They are unwilling to stop use of their current mouthwash during the 24-week study period
Trial locations and contacts
1 site in 1 country.
United States1 site
Los Angeles LGBT Center
Los Angeles, California, 90028
About this study
Official title: A Randomized Crossover Study to Evaluate the Efficacy of Antibacterial Mouthwash in Preventing Pharyngeal Gonorrhea Among a High Risk Population
This study aims to determine acceptability and preliminary efficacy of daily use of an antibacterial mouthwash as compared to a placebo mouthwash in reducing the incidence of pharyngeal gonorrhea among a cohort of HIV-positive and high risk HIV-negative men.
Investigators plan to test the following hypotheses:
- Participants will maintain a high level of adherence and satisfaction with daily mouthwash use. Furthermore, the investigators hypothesize that barriers to adherence will include structural factors such as unstable housing and individual level factors such as substance use.
- Participants receiving the antibacterial mouthwash will have a lower incidence of pharyngeal gonorrhea as compared to participants receiving the placebo mouthwash. Furthermore, the investigators hypothesize that these reductions will remain even after adjusting for other factors such as HIV-status and substance use.
Read the detailed description
The proposed study will build on the NIH/NIDA funded mSTUDY (U01 DA036267 PIs Gorbach and Shoptaw), which is a longitudinal study designed to assess the impact of substance use and HIV on minority MSM. Participants in the proposed study will be those enrolled in the mSTUDY and the objectives of this study are to measure the preliminary efficacy and acceptability of antibacterial mouthwash use for the prevention of pharyngeal gonorrhea among a cohort of high risk HIV-negative and HIV-positive MSM. In order to achieve this goal the investigators propose to conduct a double-blind, randomized, crossover trial of daily antibacterial mouthwash use as compared to a placebo mouthwash among mSTUDY participants at high risk for pharyngeal gonorrhea (i.e. previously diagnosed with pharyngeal gonorrhea). Participants will be followed for a total of 24 weeks, with each participant receiving 12-weeks of antibacterial mouthwash and 12-weeks of placebo mouthwash.
After providing written informed consent, participants will complete a computer-based questionnaire, provide biological specimen, and will be randomly allocated to their study group. The study survey will include questions that are collected as part of mSTUDY as well as questions relevant to the proposed study. Following the questionnaire, participants will provide a bio-specimen for STI testing including: (1) urine, for chlamydia and gonorrhea testing; (2) rectal and pharyngeal swabs for gonorrhea and chlamydia testing; and (3) blood, which is used for syphilis and HIV testing, and HIV-1 RNA levels (for HIV-positive).
Participants will be randomly allocated to either first receive a 12-week antibacterial mouthwash followed by 12-weeks of placebo mouthwash or start with 12-weeks of placebo mouthwash and crossover to 12-weeks of antibacterial mouthwash. The antibacterial mouthwash and placebo are commercially available products (Cool Mint Listerine® Antiseptic mouthwash and Biotene® Oral Rinse respectively) and are selected based on evidence demonstrating inhibitory effects of the antibacterial mouthwash (Cool Mint Listerine® Antiseptic mouthwash) against N. gonorrhoeae. In order to ensure concealment of study allocation and to allow for blinding, the following procedures will be instituted:
- the investigators will generate a computerized randomization sequence (active condition first, placebo second or placebo first, active condition second). The randomization sequence will be linked to the study identification number and maintained by study staff not involved in participant contact or data management/analysis;
- the mouthwash will be in bottles in such a way to ensure that the placebo and active product have an identical look. While the products packaging will have a similar look a label with the study ID will allow us to link the bottle to the content. At the time of study enrollment, all participants will receive a 12-week supply of mouthwash according to their randomized study group (antibacterial or placebo) and will be instructed on how to rinse and gargle with the mouthwash on a daily basis.
When participants return for the 12-week visit, they will receive another 12-week supply, which will be the crossover condition to what was assigned at baseline. Participants will be instructed to stop using any other mouthwash they may have been using prior to study enrollment. All participants will be asked to return to the study site for a 12-week follow-up visit. This visit is a study specific visit and is the only visit of the three study visits that does not overlap with an mSTUDY follow-up visit. Participants will be asked to complete a computer-based survey to collect information comparable to what was collected at baseline including information on sexual behaviors, substance use, and oral hygiene practices. Additionally, participants will be asked to complete questions regarding study mouthwash us including frequency and timing of mouthwash use (i.e., intervention fidelity) and acceptability of mouthwash. Pharyngeal swabs will be collected in order to test for gonorrhea including nucleic acid amplification testing (NAAT) and culture testing. All participants will be asked to return in 12-weeks (i.e., 24-weeks from baseline) which will coincide with an mSTUDY visit and data collection procedures from baseline will be repeated including laboratory testing for STIs and survey administration.
- Conditions
- Gonorrhea
- Being tested
- Listerine Antiseptic Mouthwash Product, Biotene Mouthwash
- Medical subject headings
- Gonorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Listerine Antiseptic Mouthwash ProductDrug
Also called Active Mouthwash
COOL MINT LISTERINE® Antiseptic Mouthwash will be used as the 'active' study drug condition. This is a commercially available, over the counter mouthwash product. Active ingredients for this product include Eucalyptol 0.092%, Menthol 0.042%, Methyl salicylate 0.060%, Thymol 0.064%. This product also contains 21% alcohol. Participants will be asked to rinse and gargle their mouth with 20mL of mouthwash daily.
Biotene MouthwashDrug
Also called Placebo Mouthwash
Biotène Rinse is designed with a moisturizing formula to help relieve dry mouth symptoms and is specifically designed to have a pH similar to saliva. This is a commercially available, over the counter mouthwash product. Biotène Mouthwash Ingredients include: Purified Water, Propylene Glycol, Hydrogenated Starch Hydrolysate, Poloxamer 407, Hydroxyethylcellulose, Sodium Benzoate, Flavor (Peppermint Oil), Benzoic Acid, Disodium Phosphate, Zinc Gluconate, Lactoferrin, Lysozyme, Lactoperoxidase, Potassium Thiocyanate, Aloe Vera Gel, Calcium Lactate, Glucose Oxidase. Participants will be asked to rinse and gargle their mouth with 20mL of mouthwash daily.
| Study group | Role | What they receive |
|---|---|---|
| Listerine Cool Mint Antiseptic Mouthwash | Active comparator | Daily use of an antibacterial mouthwash (Listerine Cool Mint Antiseptic Mouthwash) during the 12-week follow-up period. Receives: Drug: Listerine Antiseptic Mouthwash Product |
| Biotene Oral Rinse | Placebo comparator | Daily use of a placebo mouthwash with no known antibacterial qualities (Biotene Oral Rinse) during the 12-week follow-up period. Receives: Drug: Biotene Mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mouthwash Adherence - Percent of Days Mouthwash Used
This outcome was assessed using self-reported questionnaire data asking participants to report "In the past 3 months, what proportion of days did you use the mouthwash?"
Measured: This outcome will be measured over each 12-week intervention period
Mouthwash Acceptability - Number of Participants Who Reported it Was Hard to Gargle/Rinse With Mouthwash
This outcome will be assessed using self-reported questionnaire and is intended to measure acceptability of mouthwash as prevention strategy for pharyngeal gonnorrhea. Participants were asked "Did you experience any of the following difficulties using the mouthwash?" with answer choices including:
It was hard to gargle/rinse I didn't like the mouthwash flavor/taste It was uncomfortable Amount of liquid was too much Amount of gargling time was too long
Measured: This outcome will be measured at 12-weeks post intervention.
Mouthwash Acceptability - Number of Participants Who Did Not Like Mouthwash Flavor/Taste
This outcome will be assessed using self-reported questionnaire and is intended to measure acceptability of mouthwash as prevention strategy for pharyngeal gonnorrhea. Participants were asked "Did you experience any of the following difficulties using the mouthwash?" with answer choices including:
It was hard to gargle/rinse I didn't like the mouthwash flavor/taste It was uncomfortable Amount of liquid was too much Amount of gargling time was too long
Measured: This outcome will be measured at 12-weeks post intervention.
Mouthwash Acceptability - Number of Participants Who Said Mouthwash Use Was Uncomfortable
This outcome will be assessed using self-reported questionnaire and is intended to measure acceptability of mouthwash as prevention strategy for pharyngeal gonnorrhea. Participants were asked "Did you experience any of the following difficulties using the mouthwash?" with answer choices including:
It was hard to gargle/rinse I didn't like the mouthwash flavor/taste It was uncomfortable Amount of liquid was too much Amount of gargling time was too long
Measured: This outcome will be measured at 12-weeks post intervention.
Mouthwash Acceptability - Number of Participants Who Said Amount of Liquid Was Too Much
This outcome will be assessed using self-reported questionnaire and is intended to measure acceptability of mouthwash as prevention strategy for pharyngeal gonnorrhea. Participants were asked "Did you experience any of the following difficulties using the mouthwash?" with answer choices including:
It was hard to gargle/rinse I didn't like the mouthwash flavor/taste It was uncomfortable Amount of liquid was too much Amount of gargling time was too long
Measured: This outcome will be measured at 12-weeks post intervention.
Mouthwash Acceptability - Number of Participants Who Said Gargling Time Was Too Long
This outcome will be assessed using self-reported questionnaire and is intended to measure acceptability of mouthwash as prevention strategy for pharyngeal gonnorrhea. Participants were asked "Did you experience any of the following difficulties using the mouthwash?" with answer choices including:
It was hard to gargle/rinse I didn't like the mouthwash flavor/taste It was uncomfortable Amount of liquid was too much Amount of gargling time was too long
Measured: This outcome will be measured at 12-weeks post intervention.
Secondary outcomes (1)
Pharyngeal Gonorrhea - Laboratory Testing Results
Laboratory confirmed pharyngeal gonorrhea
Measured: Past 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start17 Feb 2022
- Primary completion16 May 2025
- Study completion12 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GonorrheaStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marjan Javanbakht, MPH, PhD, University of California, Los Angeles
- Investigators
- Marjan Javanbakht, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966507
- Sponsor's protocol ID
- R21AI147969
- Other IDs
- R21AI147969
- Status last verified
- Jun 2026
- First submitted
- 26 May 2021
- Last updated
- 9 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Crossover Study to Evaluate the Efficacy of Antibacterial Mouthwash in Preventing Pharyngeal Gonorrhea Among a High Risk Population
- ClinicalTrials.gov ID
- NCT04966507
- Acronym / sponsor ID
- R21AI147969
- Conditions
- Gonorrhea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 16 May 2025 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 19 Jul 2021 (actual)
- Results
- Posted 9 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine acceptability and preliminary efficacy of daily use of an antibacterial mouthwash as compared to a placebo mouthwash in reducing the incidence of pharyngeal gonorrhea among a cohort of HIV-positive and high risk HIV-negative men.
Investigators plan to test the following hypotheses:
- Participants will maintain a high level of adherence and satisfaction with daily mouthwash use. Furthermore, the investigators hypothesize that barriers to adherence will include structural factors such as unstable housing and individual level factors such as substance use.
- Participants receiving the antibacterial mouthwash will have a lower incidence of pharyngeal gonorrhea as compared to participants receiving the placebo mouthwash. Furthermore, the investigators hypothesize that these reductions will remain even after adjusting for other factors such as HIV-status and substance use.
Detailed description
The proposed study will build on the NIH/NIDA funded mSTUDY (U01 DA036267 PIs Gorbach and Shoptaw), which is a longitudinal study designed to assess the impact of substance use and HIV on minority MSM. Participants in the proposed study will be those enrolled in the mSTUDY and the objectives of this study are to measure the preliminary efficacy and acceptability of antibacterial mouthwash use for the prevention of pharyngeal gonorrhea among a cohort of high risk HIV-negative and HIV-positive MSM. In order to achieve this goal the investigators propose to conduct a double-blind, randomized, crossover trial of daily antibacterial mouthwash use as compared to a placebo mouthwash among mSTUDY participants at high risk for pharyngeal gonorrhea (i.e. previously diagnosed with pharyngeal gonorrhea). Participants will be followed for a total of 24 weeks, with each participant receiving 12-weeks of antibacterial mouthwash and 12-weeks of placebo mouthwash.
After providing written informed consent, participants will complete a computer-based questionnaire, provide biological specimen, and will be randomly allocated to their study group. The study survey will include questions that are collected as part of mSTUDY as well as questions relevant to the proposed study. Following the questionnaire, participants will provide a bio-specimen for STI testing including: (1) urine, for chlamydia and gonorrhea testing; (2) rectal and pharyngeal swabs for gonorrhea and chlamydia testing; and (3) blood, which is used for syphilis and HIV testing, and HIV-1 RNA levels (for HIV-positive).
Participants will be randomly allocated to either first receive a 12-week antibacterial mouthwash followed by 12-weeks of placebo mouthwash or start with 12-weeks of placebo mouthwash and crossover to 12-weeks of antibacterial mouthwash. The antibacterial mouthwash and placebo are commercially available products (Cool Mint Listerine® Antiseptic mouthwash and Biotene® Oral Rinse respectively) and are selected based on evidence demonstrating inhibitory effects of the antibacterial mouthwash (Cool Mint Listerine® Antiseptic mouthwash) against N. gonorrhoeae. In order to ensure concealment of study allocation and to allow for blinding, the following procedures will be instituted:
- the investigators will generate a computerized randomization sequence (active condition first, placebo second or placebo first, active condition second). The randomization sequence will be linked to the study identification number and maintained by study staff not involved in participant contact or data management/analysis;
- the mouthwash will be in bottles in such a way to ensure that the placebo and active product have an identical look. While the products packaging will have a similar look a label with the study ID will allow us to link the bottle to the content. At the time of study enrollment, all participants will receive a 12-week supply of mouthwash according to their randomized study group (antibacterial or placebo) and will be instructed on how to rinse and gargle with the mouthwash on a daily basis.
When participants return for the 12-week visit, they will receive another 12-week supply, which will be the crossover condition to what was assigned at baseline. Participants will be instructed to stop using any other mouthwash they may have been using prior to study enrollment. All participants will be asked to return to the study site for a 12-week follow-up visit. This visit is a study specific visit and is the only visit of the three study visits that does not overlap with an mSTUDY follow-up visit. Participants will be asked to complete a computer-based survey to collect information comparable to what was collected at baseline including information on sexual behaviors, substance use, and oral hygiene practices. Additionally, participants will be asked to complete questions regarding study mouthwash us including frequency and timing of mouthwash use (i.e., intervention fidelity) and acceptability of mouthwash. Pharyngeal swabs will be collected in order to test for gonorrhea including nucleic acid amplification testing (NAAT) and culture testing. All participants will be asked to return in 12-weeks (i.e., 24-weeks from baseline) which will coincide with an mSTUDY visit and data collection procedures from baseline will be repeated including laboratory testing for STIs and survey administration.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Listerine Cool Mint Antiseptic Mouthwash | Active comparator | Drug: Listerine Antiseptic Mouthwash ProductDaily use of an antibacterial mouthwash (Listerine Cool Mint Antiseptic Mouthwash) during the 12-week follow-up period. |
| Biotene Oral Rinse | Placebo comparator | Drug: Biotene MouthwashDaily use of a placebo mouthwash with no known antibacterial qualities (Biotene Oral Rinse) during the 12-week follow-up period. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| Listerine Antiseptic Mouthwash ProductAlso: Active MouthwashCOOL MINT LISTERINE® Antiseptic Mouthwash will be used as the 'active' study drug condition. This is a commercially available, over the counter mouthwash product. Active ingredients for this product include Eucalyptol 0.092%, Menthol 0.042%, Methyl salicylate 0.060%, Thymol 0.064%. This product also contains 21% alcohol. Participants will be asked to rinse and gargle their mouth with 20mL of mouthwash daily. | Drug | Listerine Cool Mint Antiseptic Mouthwash |
| Biotene MouthwashAlso: Placebo MouthwashBiotène Rinse is designed with a moisturizing formula to help relieve dry mouth symptoms and is specifically designed to have a pH similar to saliva. This is a commercially available, over the counter mouthwash product. Biotène Mouthwash Ingredients include: Purified Water, Propylene Glycol, Hydrogenated Starch Hydrolysate, Poloxamer 407, Hydroxyethylcellulose, Sodium Benzoate, Flavor (Peppermint Oil), Benzoic Acid, Disodium Phosphate, Zinc Gluconate, Lactoferrin, Lysozyme, Lactoperoxidase, Potassium Thiocyanate, Aloe Vera Gel, Calcium Lactate, Glucose Oxidase. Participants will be asked to rinse and gargle their mouth with 20mL of mouthwash daily. | Drug | Biotene Oral Rinse |
Primary outcome
Mouthwash Adherence - Percent of Days Mouthwash Used
Time frame: This outcome will be measured over each 12-week intervention period
This outcome was assessed using self-reported questionnaire data asking participants to report "In the past 3 months, what proportion of days did you use the mouthwash?"
Mouthwash Acceptability - Number of Participants Who Reported it Was Hard to Gargle/Rinse With Mouthwash
Time frame: This outcome will be measured at 12-weeks post intervention.
This outcome will be assessed using self-reported questionnaire and is intended to measure acceptability of mouthwash as prevention strategy for pharyngeal gonnorrhea. Participants were asked "Did you experience any of the following difficulties using the mouthwash?" with answer choices including: It was hard to gargle/rinse I didn't like the mouthwash flavor/taste It was uncomfortable Amount of liquid was too much Amount of gargling time was too long
Mouthwash Acceptability - Number of Participants Who Did Not Like Mouthwash Flavor/Taste
Time frame: This outcome will be measured at 12-weeks post intervention.
This outcome will be assessed using self-reported questionnaire and is intended to measure acceptability of mouthwash as prevention strategy for pharyngeal gonnorrhea. Participants were asked "Did you experience any of the following difficulties using the mouthwash?" with answer choices including: It was hard to gargle/rinse I didn't like the mouthwash flavor/taste It was uncomfortable Amount of liquid was too much Amount of gargling time was too long
Mouthwash Acceptability - Number of Participants Who Said Mouthwash Use Was Uncomfortable
Time frame: This outcome will be measured at 12-weeks post intervention.
This outcome will be assessed using self-reported questionnaire and is intended to measure acceptability of mouthwash as prevention strategy for pharyngeal gonnorrhea. Participants were asked "Did you experience any of the following difficulties using the mouthwash?" with answer choices including: It was hard to gargle/rinse I didn't like the mouthwash flavor/taste It was uncomfortable Amount of liquid was too much Amount of gargling time was too long
Mouthwash Acceptability - Number of Participants Who Said Amount of Liquid Was Too Much
Time frame: This outcome will be measured at 12-weeks post intervention.
This outcome will be assessed using self-reported questionnaire and is intended to measure acceptability of mouthwash as prevention strategy for pharyngeal gonnorrhea. Participants were asked "Did you experience any of the following difficulties using the mouthwash?" with answer choices including: It was hard to gargle/rinse I didn't like the mouthwash flavor/taste It was uncomfortable Amount of liquid was too much Amount of gargling time was too long
Mouthwash Acceptability - Number of Participants Who Said Gargling Time Was Too Long
Time frame: This outcome will be measured at 12-weeks post intervention.
This outcome will be assessed using self-reported questionnaire and is intended to measure acceptability of mouthwash as prevention strategy for pharyngeal gonnorrhea. Participants were asked "Did you experience any of the following difficulties using the mouthwash?" with answer choices including: It was hard to gargle/rinse I didn't like the mouthwash flavor/taste It was uncomfortable Amount of liquid was too much Amount of gargling time was too long
1 secondary outcome
Pharyngeal Gonorrhea - Laboratory Testing Results
Time frame: Past 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Marjan Javanbakht principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Listerine Antiseptic Mouthwash Product and Biotene Mouthwash in people with Gonorrhea, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 9 Jul 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mouthwash Adherence - Percent of Days Mouthwash Used (time frame: This outcome will be measured over each 12-week intervention period). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2026.