Treatment of BV With Donaxyl and a Molecular Test of Cure

Bacterial Vaginoses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04057482
• Other study ID #: 2050
• Status: Completed
• Start date: May 2015
• Est. completion date: April 2018

Study information

• Verified date: August 2019
• Source: Skaraborg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: April 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

BV

Exclusion Criteria:

No other infection (Gc, clhlamydia, trihomonas)

Related Conditions & MeSH terms

• Bacterial Vaginoses
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Drug:
• D
treatment of BV with dequalinium chloride vaginal tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Skaraborg Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cure rate of BV	how many that are cured of BV after 1 month	1 year
Secondary	Diagnosis of BV using molecular test	the Kappa index Hay/ison diagnosis and the molecular test	1 year