Trial Outcomes & Findings for Comparison of Dequalinium Chloride (Fluomizin) vs Oral Metronidazole for the Treatment of Bacterial Vaginosis (NCT NCT05788991)
NCT ID: NCT05788991
Last Updated: 2024-10-16
Results Overview
Resolution of the abnormal vaginal discharge, negative whiff test, and less than 20% clue cells
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
151 participants
Primary outcome timeframe
One week after randomization (C1)
Results posted on
2024-10-16
Participant Flow
Recruitment period: July 2021 to August 2022
Participant milestones
| Measure |
Dequalinium Chloride
Dequalinium chloride 10 mg vaginal tablets
Dequalinium Chloride: Fluomizin vaginal tablets (10 mg dequalinium chloride) used once a day for 6 days
|
Metronidazole
Metronidazole 500 mg oral tablets
Metronidazole Oral: Metronidazole oral tablets (500 mg) taken twice a day for 7 days
|
|---|---|---|
|
Overall Study
STARTED
|
73
|
78
|
|
Overall Study
COMPLETED
|
70
|
72
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
Reasons for withdrawal
| Measure |
Dequalinium Chloride
Dequalinium chloride 10 mg vaginal tablets
Dequalinium Chloride: Fluomizin vaginal tablets (10 mg dequalinium chloride) used once a day for 6 days
|
Metronidazole
Metronidazole 500 mg oral tablets
Metronidazole Oral: Metronidazole oral tablets (500 mg) taken twice a day for 7 days
|
|---|---|---|
|
Overall Study
Not treated with study medication
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
2
|
Baseline Characteristics
Comparison of Dequalinium Chloride (Fluomizin) vs Oral Metronidazole for the Treatment of Bacterial Vaginosis
Baseline characteristics by cohort
| Measure |
Dequalinium Chloride
n=72 Participants
Dequalinium chloride 10 mg vaginal tablets
Dequalinium Chloride: Fluomizin vaginal tablets (10 mg dequalinium chloride) used once a day for 6 days
|
Metronidazole
n=75 Participants
Metronidazole 500 mg oral tablets
Metronidazole Oral: Metronidazole oral tablets (500 mg) taken twice a day for 7 days
|
Total
n=147 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
37.5 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
36.7 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
72 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Nugent Score
Normal
|
18 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Nugent Score
Intermediate
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Nugent Score
Bacterial vaginosis
|
39 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Nugent Score
Missing score
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Vaginal infections in the last 12 months
|
1.0 events
n=5 Participants
|
0 events
n=7 Participants
|
1 events
n=5 Participants
|
PRIMARY outcome
Timeframe: One week after randomization (C1)Population: Patients who were randomized, treated, and with primary outcome data available
Resolution of the abnormal vaginal discharge, negative whiff test, and less than 20% clue cells
Outcome measures
| Measure |
Dequalinium Chloride
n=69 Participants
Dequalinium chloride 10 mg vaginal tablets
Dequalinium Chloride: Fluomizin vaginal tablets (10 mg dequalinium chloride) used once a day for 6 days
|
Metronidazole
n=74 Participants
Metronidazole 500 mg oral tablets
Metronidazole Oral: Metronidazole oral tablets (500 mg) taken twice a day for 7 days
|
|---|---|---|
|
Clinical Cure Rate
|
64 Participants
|
69 Participants
|
SECONDARY outcome
Timeframe: One month after randomization (C2)Resolution of the abnormal vaginal discharge, negative whiff test, and less than 20% clue cells
Outcome measures
| Measure |
Dequalinium Chloride
n=69 Participants
Dequalinium chloride 10 mg vaginal tablets
Dequalinium Chloride: Fluomizin vaginal tablets (10 mg dequalinium chloride) used once a day for 6 days
|
Metronidazole
n=71 Participants
Metronidazole 500 mg oral tablets
Metronidazole Oral: Metronidazole oral tablets (500 mg) taken twice a day for 7 days
|
|---|---|---|
|
Clinical Cure Rate
|
55 participants
|
62 participants
|
SECONDARY outcome
Timeframe: One week & one monthPopulation: Some patients were missing the Nugent score
Nugent score ≤3 Nugent score uses a 0 - 10 scale (higher score mean a worse outcome): 0 - 3 = normal flora, 4 - 6 = intermediate flora, 7 - 10 = bacterial vaginosis
Outcome measures
| Measure |
Dequalinium Chloride
n=69 Participants
Dequalinium chloride 10 mg vaginal tablets
Dequalinium Chloride: Fluomizin vaginal tablets (10 mg dequalinium chloride) used once a day for 6 days
|
Metronidazole
n=74 Participants
Metronidazole 500 mg oral tablets
Metronidazole Oral: Metronidazole oral tablets (500 mg) taken twice a day for 7 days
|
|---|---|---|
|
Bacteriological Cure Rate
Visit 1 (1 week)
|
35 Participants
|
51 Participants
|
|
Bacteriological Cure Rate
Visit 2 (1 month)
|
28 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: One week & one monthPopulation: Some patients had a missing Nugent score
Combination of clinical and bacteriological cure
Outcome measures
| Measure |
Dequalinium Chloride
n=69 Participants
Dequalinium chloride 10 mg vaginal tablets
Dequalinium Chloride: Fluomizin vaginal tablets (10 mg dequalinium chloride) used once a day for 6 days
|
Metronidazole
n=74 Participants
Metronidazole 500 mg oral tablets
Metronidazole Oral: Metronidazole oral tablets (500 mg) taken twice a day for 7 days
|
|---|---|---|
|
Therapeutic Cure
Visit 1 (1 week)
|
34 Participants
|
48 Participants
|
|
Therapeutic Cure
Visit 2 (1 month)
|
26 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: One weekPopulation: Many missing values
Efficacy was assessed by patients and investigators as 'very good', 'good', 'moderate' or 'poor'.
Outcome measures
| Measure |
Dequalinium Chloride
n=69 Participants
Dequalinium chloride 10 mg vaginal tablets
Dequalinium Chloride: Fluomizin vaginal tablets (10 mg dequalinium chloride) used once a day for 6 days
|
Metronidazole
n=74 Participants
Metronidazole 500 mg oral tablets
Metronidazole Oral: Metronidazole oral tablets (500 mg) taken twice a day for 7 days
|
|---|---|---|
|
Subjective Assessment of Efficacy
Investigator · Very Good
|
46 Participants
|
49 Participants
|
|
Subjective Assessment of Efficacy
Investigator · Good
|
18 Participants
|
20 Participants
|
|
Subjective Assessment of Efficacy
Investigator · Moderate
|
4 Participants
|
4 Participants
|
|
Subjective Assessment of Efficacy
Investigator · Poor
|
1 Participants
|
1 Participants
|
|
Subjective Assessment of Efficacy
Patient · Very Good
|
19 Participants
|
22 Participants
|
|
Subjective Assessment of Efficacy
Patient · Good
|
26 Participants
|
24 Participants
|
|
Subjective Assessment of Efficacy
Patient · Moderate
|
4 Participants
|
8 Participants
|
|
Subjective Assessment of Efficacy
Patient · Poor
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: One weekPopulation: Many missing values
Tolerability was assessed by patients as 'very good', 'good', 'moderate' or 'poor'.
Outcome measures
| Measure |
Dequalinium Chloride
n=50 Participants
Dequalinium chloride 10 mg vaginal tablets
Dequalinium Chloride: Fluomizin vaginal tablets (10 mg dequalinium chloride) used once a day for 6 days
|
Metronidazole
n=54 Participants
Metronidazole 500 mg oral tablets
Metronidazole Oral: Metronidazole oral tablets (500 mg) taken twice a day for 7 days
|
|---|---|---|
|
Subjective Assessment of Tolerability
Very good
|
30 Participants
|
21 Participants
|
|
Subjective Assessment of Tolerability
Good
|
17 Participants
|
26 Participants
|
|
Subjective Assessment of Tolerability
Moderate
|
3 Participants
|
4 Participants
|
|
Subjective Assessment of Tolerability
Poor
|
0 Participants
|
3 Participants
|
POST_HOC outcome
Timeframe: 1 week and 1 monthPopulation: Missing some outcome measures
Amsel criteria = presence of abnormal vaginal discharge, whiff test (fishy odor), clue cells, and pH \>4.5 Bacterial vaginosis = 3 or more Amsel criteria present Cure = absence of 2 or more Amsel criteria
Outcome measures
| Measure |
Dequalinium Chloride
n=69 Participants
Dequalinium chloride 10 mg vaginal tablets
Dequalinium Chloride: Fluomizin vaginal tablets (10 mg dequalinium chloride) used once a day for 6 days
|
Metronidazole
n=74 Participants
Metronidazole 500 mg oral tablets
Metronidazole Oral: Metronidazole oral tablets (500 mg) taken twice a day for 7 days
|
|---|---|---|
|
Patients Cured Based on Standard Amsel Criteria
One month
|
61 Participants
|
67 Participants
|
|
Patients Cured Based on Standard Amsel Criteria
One week
|
68 Participants
|
73 Participants
|
Adverse Events
Dequalinium Chloride
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Metronidazole
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dequalinium Chloride
n=72 participants at risk
Dequalinium chloride 10 mg vaginal tablets
Dequalinium Chloride: Fluomizin vaginal tablets (10 mg dequalinium chloride) used once a day for 6 days
|
Metronidazole
n=75 participants at risk
Metronidazole 500 mg oral tablets
Metronidazole Oral: Metronidazole oral tablets (500 mg) taken twice a day for 7 days
|
|---|---|---|
|
Reproductive system and breast disorders
Candidiasis
|
2.8%
2/72 • Number of events 2 • 1 month
Safety population included patients who received treatment with study medication (dequalinium chloride or metronidazole). Treatment-emergent adverse events, defined as adverse events occurring within 24 days of randomization.
|
5.3%
4/75 • Number of events 4 • 1 month
Safety population included patients who received treatment with study medication (dequalinium chloride or metronidazole). Treatment-emergent adverse events, defined as adverse events occurring within 24 days of randomization.
|
|
Reproductive system and breast disorders
vaginal infection
|
1.4%
1/72 • Number of events 1 • 1 month
Safety population included patients who received treatment with study medication (dequalinium chloride or metronidazole). Treatment-emergent adverse events, defined as adverse events occurring within 24 days of randomization.
|
0.00%
0/75 • 1 month
Safety population included patients who received treatment with study medication (dequalinium chloride or metronidazole). Treatment-emergent adverse events, defined as adverse events occurring within 24 days of randomization.
|
|
Reproductive system and breast disorders
Vulvovaginal burnining sensation
|
0.00%
0/72 • 1 month
Safety population included patients who received treatment with study medication (dequalinium chloride or metronidazole). Treatment-emergent adverse events, defined as adverse events occurring within 24 days of randomization.
|
2.7%
2/75 • Number of events 2 • 1 month
Safety population included patients who received treatment with study medication (dequalinium chloride or metronidazole). Treatment-emergent adverse events, defined as adverse events occurring within 24 days of randomization.
|
|
Gastrointestinal disorders
Dysgeusia
|
1.4%
1/72 • Number of events 1 • 1 month
Safety population included patients who received treatment with study medication (dequalinium chloride or metronidazole). Treatment-emergent adverse events, defined as adverse events occurring within 24 days of randomization.
|
1.3%
1/75 • Number of events 1 • 1 month
Safety population included patients who received treatment with study medication (dequalinium chloride or metronidazole). Treatment-emergent adverse events, defined as adverse events occurring within 24 days of randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Pruritus
|
1.4%
1/72 • Number of events 1 • 1 month
Safety population included patients who received treatment with study medication (dequalinium chloride or metronidazole). Treatment-emergent adverse events, defined as adverse events occurring within 24 days of randomization.
|
0.00%
0/75 • 1 month
Safety population included patients who received treatment with study medication (dequalinium chloride or metronidazole). Treatment-emergent adverse events, defined as adverse events occurring within 24 days of randomization.
|
|
General disorders
Pharyngeal swelling
|
2.8%
2/72 • Number of events 2 • 1 month
Safety population included patients who received treatment with study medication (dequalinium chloride or metronidazole). Treatment-emergent adverse events, defined as adverse events occurring within 24 days of randomization.
|
0.00%
0/75 • 1 month
Safety population included patients who received treatment with study medication (dequalinium chloride or metronidazole). Treatment-emergent adverse events, defined as adverse events occurring within 24 days of randomization.
|
|
Reproductive system and breast disorders
Vulvovaginal swelling
|
0.00%
0/72 • 1 month
Safety population included patients who received treatment with study medication (dequalinium chloride or metronidazole). Treatment-emergent adverse events, defined as adverse events occurring within 24 days of randomization.
|
1.3%
1/75 • Number of events 1 • 1 month
Safety population included patients who received treatment with study medication (dequalinium chloride or metronidazole). Treatment-emergent adverse events, defined as adverse events occurring within 24 days of randomization.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/72 • 1 month
Safety population included patients who received treatment with study medication (dequalinium chloride or metronidazole). Treatment-emergent adverse events, defined as adverse events occurring within 24 days of randomization.
|
1.3%
1/75 • Number of events 1 • 1 month
Safety population included patients who received treatment with study medication (dequalinium chloride or metronidazole). Treatment-emergent adverse events, defined as adverse events occurring within 24 days of randomization.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/72 • 1 month
Safety population included patients who received treatment with study medication (dequalinium chloride or metronidazole). Treatment-emergent adverse events, defined as adverse events occurring within 24 days of randomization.
|
1.3%
1/75 • Number of events 1 • 1 month
Safety population included patients who received treatment with study medication (dequalinium chloride or metronidazole). Treatment-emergent adverse events, defined as adverse events occurring within 24 days of randomization.
|
|
General disorders
Fatigue
|
0.00%
0/72 • 1 month
Safety population included patients who received treatment with study medication (dequalinium chloride or metronidazole). Treatment-emergent adverse events, defined as adverse events occurring within 24 days of randomization.
|
1.3%
1/75 • Number of events 1 • 1 month
Safety population included patients who received treatment with study medication (dequalinium chloride or metronidazole). Treatment-emergent adverse events, defined as adverse events occurring within 24 days of randomization.
|
|
General disorders
Headache
|
1.4%
1/72 • Number of events 1 • 1 month
Safety population included patients who received treatment with study medication (dequalinium chloride or metronidazole). Treatment-emergent adverse events, defined as adverse events occurring within 24 days of randomization.
|
0.00%
0/75 • 1 month
Safety population included patients who received treatment with study medication (dequalinium chloride or metronidazole). Treatment-emergent adverse events, defined as adverse events occurring within 24 days of randomization.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place