Trial · NCT05788991

Comparison of Dequalinium Chloride (Fluomizin) vs Oral Metronidazole for the Treatment of Bacterial Vaginosis

NCT05788991, Phase 4, Terminated, Medinova AG; results first posted 2024-10-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Comparison of Dequalinium Chloride (Fluomizin) vs Oral Metronidazole for the Treatment of Bacterial Vaginosis. Trials, record NCT05788991. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05788991

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Comparison of Dequalinium Chloride (Fluomizin) vs Oral Metronidazole for the Treatment of Bacterial Vaginosis
NCT number: NCT05788991
Status: Terminated
Phases: Phase 4
Enrollment: 151 participants, actual
Lead sponsor: Medinova AG
Conditions: Bacterial Vaginosis, Vaginal Infection, Vaginal Diseases
Interventions: Dequalinium Chloride, Metronidazole Oral
First posted: 2023-03-29
Last updated: 2024-10-16
Other registries' IDs: eudract:2020-002489-15
Results first posted: 2024-10-16

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Clinical Cure Rate	One week after randomization (C1)	Resolution of the abnormal vaginal discharge, negative whiff test, and less than 20% clue cells
Secondary	Clinical Cure Rate	One month after randomization (C2)	Resolution of the abnormal vaginal discharge, negative whiff test, and less than 20% clue cells
Secondary	Bacteriological Cure Rate	One week & one month	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
Secondary	Therapeutic Cure	One week & one month	Combination of clinical and bacteriological cure
Secondary	Subjective Assessment of Efficacy	One week	Efficacy was assessed by patients and investigators as 'very good', 'good', 'moderate' or 'poor'.
Secondary	Subjective Assessment of Tolerability	One week	Tolerability was assessed by patients as 'very good', 'good', 'moderate' or 'poor'.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Clinical Cure Rate	One week after randomization (C1)	Patients who were randomized, treated, and with primary outcome data available	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Clinical Cure Rate	One month after randomization (C2)		participants	NUMBER
SECONDARY	Bacteriological Cure Rate	One week & one month	Some patients were missing the Nugent score	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Therapeutic Cure	One week & one month	Some patients had a missing Nugent score	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Subjective Assessment of Efficacy	One week	Many missing values	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Subjective Assessment of Tolerability	One week	Many missing values	Participants	COUNT_OF_PARTICIPANTS
POST_HOC	Patients Cured Based on Standard Amsel Criteria	1 week and 1 month	Missing some outcome measures	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group40

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Clinical Cure Rate	Dequalinium Chloride		64	Participants
Clinical Cure Rate	Metronidazole		69	Participants
Clinical Cure Rate	Dequalinium Chloride		55	participants
Clinical Cure Rate	Metronidazole		62	participants
Bacteriological Cure Rate	Dequalinium Chloride	Visit 1 (1 week)	35	Participants
Bacteriological Cure Rate	Metronidazole	Visit 1 (1 week)	51	Participants
Bacteriological Cure Rate	Dequalinium Chloride	Visit 2 (1 month)	28	Participants
Bacteriological Cure Rate	Metronidazole	Visit 2 (1 month)	38	Participants
Therapeutic Cure	Dequalinium Chloride	Visit 1 (1 week)	34	Participants
Therapeutic Cure	Metronidazole	Visit 1 (1 week)	48	Participants

1 to 10 of 40Source ClinicalTrials.gov

See all 40 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Dequalinium Chloride	73
Overall Study	STARTED	Metronidazole	78
Overall Study	COMPLETED	Dequalinium Chloride	70
Overall Study	COMPLETED	Metronidazole	72
Overall Study	NOT COMPLETED	Dequalinium Chloride	3
Overall Study	NOT COMPLETED	Metronidazole	6

Source ClinicalTrials.gov

Adverse events22

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Candidiasis	Reproductive system and breast disorders	Dequalinium Chloride	2	72	2
other	Candidiasis	Reproductive system and breast disorders	Metronidazole	4	75	4
other	vaginal infection	Reproductive system and breast disorders	Dequalinium Chloride	1	72	1
other	vaginal infection	Reproductive system and breast disorders	Metronidazole	0	75	0
other	Vulvovaginal burnining sensation	Reproductive system and breast disorders	Dequalinium Chloride	0	72	0
other	Vulvovaginal burnining sensation	Reproductive system and breast disorders	Metronidazole	2	75	2
other	Dysgeusia	Gastrointestinal disorders	Dequalinium Chloride	1	72	1
other	Dysgeusia	Gastrointestinal disorders	Metronidazole	1	75	1
other	Pruritus	Respiratory, thoracic and mediastinal disorders	Dequalinium Chloride	1	72	1
other	Pruritus	Respiratory, thoracic and mediastinal disorders	Metronidazole	0	75	0

1 to 10 of 22Source ClinicalTrials.gov

See all 22 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Dequalinium Chloride	0	72
Total, all-cause mortality	Metronidazole	0	75
Total, other adverse events	Dequalinium Chloride	4	72
Total, other adverse events	Metronidazole	10	75
Total, serious adverse events	Dequalinium Chloride	0	72
Total, serious adverse events	Metronidazole	0	75

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
38696172	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Dequalinium Chloride vs Metronidazole: Clinical Cure Rate	Trial comparisons
Dequalinium Chloride vs Metronidazole: Clinical Cure Rate	Trial comparisons
Dequalinium Chloride vs Metronidazole: deaths from any cause	Trial comparisons
Dequalinium Chloride vs Metronidazole: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT05788991

GET https://conductscience.org/api/trials/v1/NCT05788991/results?page=2

API reference For AI assistants