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Treatment of BV With Donaxyl and a Molecular Test of Cure

Treatment of Bacterial Vaginosis With Dequalinium Chloride Vaginal Tablets and a Test of Cure Using a New Molecular Diagnostic Test for the Diagnosis of Bacterial Vaginosis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04057482
Enrollment
58
Registered
2019-08-15
Start date
2015-05-31
Completion date
2018-04-30
Last updated
2019-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Vaginoses

Keywords

Bacterial vaginosis, polymerase chain reaction, molecular diagnostic

Brief summary

. Treatment with dequalinium chloride vaginal tablets for 6 days had a cure rate lower than expected; only 37% of patients were considered cured one month after treatment.

Detailed description

This is the first study to utilize a molecular diagnostic test as a test of cure for bacterial vaginosis. The Nugent score is a reliable method for diagnosing bacterial vaginosis, but similar to traditional clinical diagnostic methods, it is not equally reliable when utilized as a test of cure. This study demonstrated that molecular diagnostic testing can be used as a test of cure and this is the first molecular test that can do that. Treatment with dequalinium chloride vaginal tablets for 6 days had a cure rate lower than expected; only 37% of patients were considered cured one month after treatment.

Interventions

DRUGD

treatment of BV with dequalinium chloride vaginal tablets

Sponsors

Skaraborg Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

BV

Exclusion criteria

No other infection (Gc, clhlamydia, trihomonas)

Design outcomes

Primary

MeasureTime frameDescription
cure rate of BV1 yearhow many that are cured of BV after 1 month

Secondary

MeasureTime frameDescription
Diagnosis of BV using molecular test1 yearthe Kappa index Hay/ison diagnosis and the molecular test

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026