Treatment of BV With Donaxyl and a Molecular Test of Cure

NCT ID: NCT04057482

Last Updated: 2019-08-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 58 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2018-04-30

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.

Conditions

Bacterial Vaginoses

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

D

treatment of BV with dequalinium chloride vaginal tablets

Intervention Type: DRUG

Other Intervention Names

dequalinium chloride vaginal tablets

Eligibility Criteria

Inclusion Criteria

BV

Exclusion Criteria

No other infection (Gc, clhlamydia, trihomonas)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Skaraborg Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Per-Goran Larsson

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

P-G Larsson, PhD

Role: PRINCIPAL_INVESTIGATOR

överläkare

Other Identifiers

2050

Identifier Type: -

Identifier Source: org_study_id