Trial Outcomes & Findings for Antibacterial Mouthwash for Pharyngeal Gonorrhea Prevention (NCT NCT04966507)
NCT ID: NCT04966507
Last Updated: 2026-07-09
Results Overview
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?"
COMPLETED
PHASE2
89 participants
This outcome will be measured over each 12-week intervention period
2026-07-09
Participant Flow
Participants in this study were drawn from mSTUDY, an NIH/NIDA-funded longitudinal cohort study (U01 DA036267) designed to examine the impact of substance use and HIV among men. Participants in mSTUDY were recruited from two sites: a community-based organization providing sexual health services and a university-affiliated research clinic. Recruitment for this study began in February 2022 and concluded in August 2024.
Participant milestones
| Measure |
Listerine Cool Mint Antiseptic Mouthwash, Then Biotene Oral Rinse
Daily use of an antibacterial mouthwash (Listerine Cool Mint Antiseptic Mouthwash) for 12-weeks, followed by daily use of a placebo mouthwash (Biotene Oral Rinse) for 12-weeks.
|
Biotene Oral Rinse, Then Listerine Cool Mint Antiseptic Mouthwash
Daily use of a placebo mouthwash (Biotene Oral Rinse) for 12-weeks, followed by 12-weeks of dialy use of an antibacterial mouthwash (Listerine Cool Mint Antiseptic Mouthwash)
|
|---|---|---|
|
Period 1: First Intervention (12 weeks)
STARTED
|
45
|
44
|
|
Period 1: First Intervention (12 weeks)
COMPLETED
|
32
|
32
|
|
Period 1: First Intervention (12 weeks)
NOT COMPLETED
|
13
|
12
|
|
Period 2: Second Intervention (12 weeks)
STARTED
|
32
|
32
|
|
Period 2: Second Intervention (12 weeks)
COMPLETED
|
31
|
28
|
|
Period 2: Second Intervention (12 weeks)
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
This is a cross over with the same 89 participants completing both study arms
Baseline characteristics by cohort
| Measure |
Listerine Cool Mint Antiseptic Mouthwash, Then Biotene Oral Rinse
n=45 Participants
Daily use of an antibacterial mouthwash (Listerine Cool Mint Antiseptic Mouthwash) for 12-weeks, followed by daily use of a placebo mouthwash (Biotene Oral Rinse) for 12-weeks.
|
Biotene Oral Rinse, Then Listerine Cool Mint Antiseptic Mouthwash
n=44 Participants
Daily use of a placebo mouthwash (Biotene Oral Rinse) for 12-weeks, followed by 12-weeks of dialy use of an antibacterial mouthwash (Listerine Cool Mint Antiseptic Mouthwash)
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39 Years
n=20 Participants • This is a cross over with the same 89 participants completing both study arms
|
37 Years
n=20 Participants • This is a cross over with the same 89 participants completing both study arms
|
38 Years
n=40 Participants • This is a cross over with the same 89 participants completing both study arms
|
|
Sex: Female, Male
Female
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=20 Participants
|
44 Participants
n=20 Participants
|
89 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
African American/Black, non-Hispanic
|
8 Participants
n=20 Participants
|
16 Participants
n=20 Participants
|
24 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
22 Participants
n=20 Participants
|
21 Participants
n=20 Participants
|
43 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
White, non-Hispanic
|
11 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: This outcome will be measured over each 12-week intervention periodPopulation: Among the 45 participants assigned to the active-to-placebo sequence and the 44 participants assigned to the placebo-to-active sequence, 32 participants in each sequence completed the first 12-week follow-up assessment. Among the 32 participants in active-to-placebo sequence that completed the 12-week assessment, 31 completed the 24-week assess. Among the 32 participants in placebo-to-active sequence that completed the 12-week assessment, 28 completed the 24-week assess.
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?"
Outcome measures
| Measure |
Listerine Cool Mint Antiseptic Mouthwash, Then Biotene Oral Rinse
n=32 Participants
Daily use of an antibacterial mouthwash (Listerine Cool Mint Antiseptic Mouthwash) for 12-weeks, followed by daily use of a placebo mouthwash (Biotene Oral Rinse) for 12-weeks.
|
Biotene Oral Rinse, Then Listerine Cool Mint Antiseptic Mouthwash
n=32 Participants
Daily use of a placebo mouthwash (Biotene Oral Rinse) for 12-weeks, followed by 12-weeks of dialy use of an antibacterial mouthwash (Listerine Cool Mint Antiseptic Mouthwash)
|
|---|---|---|
|
Mouthwash Adherence - Percent of Days Mouthwash Used
Period 2 (second 12-weeks after crossover) · Lost to follow-up
|
1 Participants
|
4 Participants
|
|
Mouthwash Adherence - Percent of Days Mouthwash Used
Period 1 (first 12-weeks) · 75%-100% of days
|
22 Participants
|
22 Participants
|
|
Mouthwash Adherence - Percent of Days Mouthwash Used
Period 1 (first 12-weeks) · 50%-74% of days
|
5 Participants
|
5 Participants
|
|
Mouthwash Adherence - Percent of Days Mouthwash Used
Period 1 (first 12-weeks) · 25%-49% of days
|
3 Participants
|
3 Participants
|
|
Mouthwash Adherence - Percent of Days Mouthwash Used
Period 1 (first 12-weeks) · 0%-24% of days
|
2 Participants
|
2 Participants
|
|
Mouthwash Adherence - Percent of Days Mouthwash Used
Period 1 (first 12-weeks) · Lost to follow-up
|
0 Participants
|
0 Participants
|
|
Mouthwash Adherence - Percent of Days Mouthwash Used
Period 2 (second 12-weeks after crossover) · 75%-100% of days
|
16 Participants
|
16 Participants
|
|
Mouthwash Adherence - Percent of Days Mouthwash Used
Period 2 (second 12-weeks after crossover) · 50%-74% of days
|
10 Participants
|
8 Participants
|
|
Mouthwash Adherence - Percent of Days Mouthwash Used
Period 2 (second 12-weeks after crossover) · 25%-49% of days
|
2 Participants
|
3 Participants
|
|
Mouthwash Adherence - Percent of Days Mouthwash Used
Period 2 (second 12-weeks after crossover) · 0%-24% of days
|
3 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: This outcome will be measured at 12-weeks post intervention.Population: Among the 45 participants assigned to the active-to-placebo sequence and the 44 participants assigned to the placebo-to-active sequence, 32 participants in each sequence completed the first 12-week follow-up assessment. Among the 32 participants in active-to-placebo sequence that completed the 12-week assessment, 31 completed the 24-week assess. Among the 32 participants in placebo-to-active sequence that completed the 12-week assessment, 28 completed the 24-week assess.
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
Outcome measures
| Measure |
Listerine Cool Mint Antiseptic Mouthwash, Then Biotene Oral Rinse
n=32 Participants
Daily use of an antibacterial mouthwash (Listerine Cool Mint Antiseptic Mouthwash) for 12-weeks, followed by daily use of a placebo mouthwash (Biotene Oral Rinse) for 12-weeks.
|
Biotene Oral Rinse, Then Listerine Cool Mint Antiseptic Mouthwash
n=32 Participants
Daily use of a placebo mouthwash (Biotene Oral Rinse) for 12-weeks, followed by 12-weeks of dialy use of an antibacterial mouthwash (Listerine Cool Mint Antiseptic Mouthwash)
|
|---|---|---|
|
Mouthwash Acceptability - Number of Participants Who Reported it Was Hard to Gargle/Rinse With Mouthwash
Period 1 (first 12-weeks) · It was hard to gargle/rinse
|
1 Participants
|
2 Participants
|
|
Mouthwash Acceptability - Number of Participants Who Reported it Was Hard to Gargle/Rinse With Mouthwash
Period 1 (first 12-weeks) · It was not hard to gargle/rinse
|
31 Participants
|
30 Participants
|
|
Mouthwash Acceptability - Number of Participants Who Reported it Was Hard to Gargle/Rinse With Mouthwash
Period 1 (first 12-weeks) · Lost to follow-up
|
0 Participants
|
0 Participants
|
|
Mouthwash Acceptability - Number of Participants Who Reported it Was Hard to Gargle/Rinse With Mouthwash
Period 2 (second 12-weeks after crossover) · It was hard to gargle/rinse
|
3 Participants
|
1 Participants
|
|
Mouthwash Acceptability - Number of Participants Who Reported it Was Hard to Gargle/Rinse With Mouthwash
Period 2 (second 12-weeks after crossover) · It was not hard to gargle/rinse
|
28 Participants
|
27 Participants
|
|
Mouthwash Acceptability - Number of Participants Who Reported it Was Hard to Gargle/Rinse With Mouthwash
Period 2 (second 12-weeks after crossover) · Lost to follow-up
|
1 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: This outcome will be measured at 12-weeks post intervention.Population: Among the 45 participants assigned to the active-to-placebo sequence and the 44 participants assigned to the placebo-to-active sequence, 32 participants in each sequence completed the first 12-week follow-up assessment. Among the 32 participants in active-to-placebo sequence that completed the 12-week assessment, 31 completed the 24-week assess. Among the 32 participants in placebo-to-active sequence that completed the 12-week assessment, 28 completed the 24-week assess.
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
Outcome measures
| Measure |
Listerine Cool Mint Antiseptic Mouthwash, Then Biotene Oral Rinse
n=32 Participants
Daily use of an antibacterial mouthwash (Listerine Cool Mint Antiseptic Mouthwash) for 12-weeks, followed by daily use of a placebo mouthwash (Biotene Oral Rinse) for 12-weeks.
|
Biotene Oral Rinse, Then Listerine Cool Mint Antiseptic Mouthwash
n=32 Participants
Daily use of a placebo mouthwash (Biotene Oral Rinse) for 12-weeks, followed by 12-weeks of dialy use of an antibacterial mouthwash (Listerine Cool Mint Antiseptic Mouthwash)
|
|---|---|---|
|
Mouthwash Acceptability - Number of Participants Who Did Not Like Mouthwash Flavor/Taste
Period 1 (first 12-weeks) · Disliked mouthwash taste/flavor
|
4 Participants
|
4 Participants
|
|
Mouthwash Acceptability - Number of Participants Who Did Not Like Mouthwash Flavor/Taste
Period 1 (first 12-weeks) · Did not dislike mouthwash taste/flavor
|
28 Participants
|
28 Participants
|
|
Mouthwash Acceptability - Number of Participants Who Did Not Like Mouthwash Flavor/Taste
Period 1 (first 12-weeks) · Lost to follow-up
|
0 Participants
|
0 Participants
|
|
Mouthwash Acceptability - Number of Participants Who Did Not Like Mouthwash Flavor/Taste
Period 2 (second 12-weeks after crossover) · Disliked mouthwash taste/flavor
|
1 Participants
|
4 Participants
|
|
Mouthwash Acceptability - Number of Participants Who Did Not Like Mouthwash Flavor/Taste
Period 2 (second 12-weeks after crossover) · Did not dislike mouthwash taste/flavor
|
30 Participants
|
24 Participants
|
|
Mouthwash Acceptability - Number of Participants Who Did Not Like Mouthwash Flavor/Taste
Period 2 (second 12-weeks after crossover) · Lost to follow-up
|
1 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: This outcome will be measured at 12-weeks post intervention.Population: Among the 45 participants assigned to the active-to-placebo sequence and the 44 participants assigned to the placebo-to-active sequence, 32 participants in each sequence completed the first 12-week follow-up assessment. Among the 32 participants in active-to-placebo sequence that completed the 12-week assessment, 31 completed the 24-week assess. Among the 32 participants in placebo-to-active sequence that completed the 12-week assessment, 28 completed the 24-week assess.
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
Outcome measures
| Measure |
Listerine Cool Mint Antiseptic Mouthwash, Then Biotene Oral Rinse
n=32 Participants
Daily use of an antibacterial mouthwash (Listerine Cool Mint Antiseptic Mouthwash) for 12-weeks, followed by daily use of a placebo mouthwash (Biotene Oral Rinse) for 12-weeks.
|
Biotene Oral Rinse, Then Listerine Cool Mint Antiseptic Mouthwash
n=32 Participants
Daily use of a placebo mouthwash (Biotene Oral Rinse) for 12-weeks, followed by 12-weeks of dialy use of an antibacterial mouthwash (Listerine Cool Mint Antiseptic Mouthwash)
|
|---|---|---|
|
Mouthwash Acceptability - Number of Participants Who Said Mouthwash Use Was Uncomfortable
Period 1 (first 12-weeks) · Mouthwash use was uncomfortable
|
4 Participants
|
0 Participants
|
|
Mouthwash Acceptability - Number of Participants Who Said Mouthwash Use Was Uncomfortable
Period 1 (first 12-weeks) · Mouthwash use was not uncomfortable
|
28 Participants
|
32 Participants
|
|
Mouthwash Acceptability - Number of Participants Who Said Mouthwash Use Was Uncomfortable
Period 1 (first 12-weeks) · Lost to follow-up
|
0 Participants
|
0 Participants
|
|
Mouthwash Acceptability - Number of Participants Who Said Mouthwash Use Was Uncomfortable
Period 2 (second 12-weeks after crossover) · Mouthwash use was uncomfortable
|
2 Participants
|
1 Participants
|
|
Mouthwash Acceptability - Number of Participants Who Said Mouthwash Use Was Uncomfortable
Period 2 (second 12-weeks after crossover) · Mouthwash use was not uncomfortable
|
29 Participants
|
27 Participants
|
|
Mouthwash Acceptability - Number of Participants Who Said Mouthwash Use Was Uncomfortable
Period 2 (second 12-weeks after crossover) · Lost to follow-up
|
1 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: This outcome will be measured at 12-weeks post intervention.Population: Among the 45 participants assigned to the active-to-placebo sequence and the 44 participants assigned to the placebo-to-active sequence, 32 participants in each sequence completed the first 12-week follow-up assessment. Among the 32 participants in active-to-placebo sequence that completed the 12-week assessment, 31 completed the 24-week assess. Among the 32 participants in placebo-to-active sequence that completed the 12-week assessment, 28 completed the 24-week assess.
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
Outcome measures
| Measure |
Listerine Cool Mint Antiseptic Mouthwash, Then Biotene Oral Rinse
n=32 Participants
Daily use of an antibacterial mouthwash (Listerine Cool Mint Antiseptic Mouthwash) for 12-weeks, followed by daily use of a placebo mouthwash (Biotene Oral Rinse) for 12-weeks.
|
Biotene Oral Rinse, Then Listerine Cool Mint Antiseptic Mouthwash
n=32 Participants
Daily use of a placebo mouthwash (Biotene Oral Rinse) for 12-weeks, followed by 12-weeks of dialy use of an antibacterial mouthwash (Listerine Cool Mint Antiseptic Mouthwash)
|
|---|---|---|
|
Mouthwash Acceptability - Number of Participants Who Said Amount of Liquid Was Too Much
Period 1 (first 12-weeks) · Amount of liquid was too much
|
2 Participants
|
0 Participants
|
|
Mouthwash Acceptability - Number of Participants Who Said Amount of Liquid Was Too Much
Period 1 (first 12-weeks) · Amount of liquid was not too much
|
30 Participants
|
32 Participants
|
|
Mouthwash Acceptability - Number of Participants Who Said Amount of Liquid Was Too Much
Period 1 (first 12-weeks) · Lost to follow-up
|
0 Participants
|
0 Participants
|
|
Mouthwash Acceptability - Number of Participants Who Said Amount of Liquid Was Too Much
Period 2 (second 12-weeks after crossover) · Amount of liquid was too much
|
1 Participants
|
1 Participants
|
|
Mouthwash Acceptability - Number of Participants Who Said Amount of Liquid Was Too Much
Period 2 (second 12-weeks after crossover) · Amount of liquid was not too much
|
30 Participants
|
27 Participants
|
|
Mouthwash Acceptability - Number of Participants Who Said Amount of Liquid Was Too Much
Period 2 (second 12-weeks after crossover) · Lost to follow-up
|
1 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: This outcome will be measured at 12-weeks post intervention.Population: Among the 45 participants assigned to the active-to-placebo sequence and the 44 participants assigned to the placebo-to-active sequence, 32 participants in each sequence completed the first 12-week follow-up assessment. Among the 32 participants in active-to-placebo sequence that completed the 12-week assessment, 31 completed the 24-week assess. Among the 32 participants in placebo-to-active sequence that completed the 12-week assessment, 28 completed the 24-week assess.
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
Outcome measures
| Measure |
Listerine Cool Mint Antiseptic Mouthwash, Then Biotene Oral Rinse
n=32 Participants
Daily use of an antibacterial mouthwash (Listerine Cool Mint Antiseptic Mouthwash) for 12-weeks, followed by daily use of a placebo mouthwash (Biotene Oral Rinse) for 12-weeks.
|
Biotene Oral Rinse, Then Listerine Cool Mint Antiseptic Mouthwash
n=32 Participants
Daily use of a placebo mouthwash (Biotene Oral Rinse) for 12-weeks, followed by 12-weeks of dialy use of an antibacterial mouthwash (Listerine Cool Mint Antiseptic Mouthwash)
|
|---|---|---|
|
Mouthwash Acceptability - Number of Participants Who Said Gargling Time Was Too Long
Period 2 (second 12-weeks after crossover) · Gargling time was not too long
|
30 Participants
|
27 Participants
|
|
Mouthwash Acceptability - Number of Participants Who Said Gargling Time Was Too Long
Period 1 (first 12-weeks) · Gargling time was too long
|
2 Participants
|
3 Participants
|
|
Mouthwash Acceptability - Number of Participants Who Said Gargling Time Was Too Long
Period 1 (first 12-weeks) · Gargling time was not too long
|
30 Participants
|
29 Participants
|
|
Mouthwash Acceptability - Number of Participants Who Said Gargling Time Was Too Long
Period 1 (first 12-weeks) · Lost to follow-up
|
0 Participants
|
0 Participants
|
|
Mouthwash Acceptability - Number of Participants Who Said Gargling Time Was Too Long
Period 2 (second 12-weeks after crossover) · Gargling time was too long
|
1 Participants
|
1 Participants
|
|
Mouthwash Acceptability - Number of Participants Who Said Gargling Time Was Too Long
Period 2 (second 12-weeks after crossover) · Lost to follow-up
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Past 12 weeksPopulation: Among the 45 participants assigned to the active-to-placebo sequence and the 44 participants assigned to the placebo-to-active sequence, 32 participants in each sequence completed the first 12-week follow-up assessment. Among the 32 participants in active-to-placebo sequence that completed the 12-week assessment, 31 completed the 24-week assess. Among the 32 participants in placebo-to-active sequence that completed the 12-week assessment, 28 completed the 24-week assess.
Laboratory confirmed pharyngeal gonorrhea
Outcome measures
| Measure |
Listerine Cool Mint Antiseptic Mouthwash, Then Biotene Oral Rinse
n=32 Participants
Daily use of an antibacterial mouthwash (Listerine Cool Mint Antiseptic Mouthwash) for 12-weeks, followed by daily use of a placebo mouthwash (Biotene Oral Rinse) for 12-weeks.
|
Biotene Oral Rinse, Then Listerine Cool Mint Antiseptic Mouthwash
n=32 Participants
Daily use of a placebo mouthwash (Biotene Oral Rinse) for 12-weeks, followed by 12-weeks of dialy use of an antibacterial mouthwash (Listerine Cool Mint Antiseptic Mouthwash)
|
|---|---|---|
|
Pharyngeal Gonorrhea - Laboratory Testing Results
Pharyngeal gonorrhea laboratory results, period 1 (first 12-weeks) · Positive
|
2 Participants
|
0 Participants
|
|
Pharyngeal Gonorrhea - Laboratory Testing Results
Pharyngeal gonorrhea laboratory results, period 1 (first 12-weeks) · Negative
|
30 Participants
|
32 Participants
|
|
Pharyngeal Gonorrhea - Laboratory Testing Results
Pharyngeal gonorrhea laboratory results, period 1 (first 12-weeks) · Not Done
|
0 Participants
|
0 Participants
|
|
Pharyngeal Gonorrhea - Laboratory Testing Results
Pharyngeal gonorrhea laboratory results, period 2 (second 12-weeks after crossover) · Positive
|
0 Participants
|
1 Participants
|
|
Pharyngeal Gonorrhea - Laboratory Testing Results
Pharyngeal gonorrhea laboratory results, period 2 (second 12-weeks after crossover) · Negative
|
31 Participants
|
27 Participants
|
|
Pharyngeal Gonorrhea - Laboratory Testing Results
Pharyngeal gonorrhea laboratory results, period 2 (second 12-weeks after crossover) · Not Done
|
1 Participants
|
4 Participants
|
Adverse Events
1. Listerine Cool Mint Antiseptic Mouthwash
Biotene Oral Rinse
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Marjan Javanbakht
University of California Los Angeles
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place