Treatment of BV With Donaxyl and a Molecular Test of Cure

. 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.

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Key information

Conditions

Bacterial Vaginoses Bacterial Infections Bacterial Infections and Mycoses Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Urogenital Diseases Vaginal Diseases Vaginitis Vaginosis, Bacterial

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Exclusion criteria

No other infection (Gc, clhlamydia, trihomonas)

Treatment and study plan

D

Drug

treatment of BV with dequalinium chloride vaginal tablets

Other names: dequalinium chloride vaginal tablets

Primary outcomes

cure rate of BV

Time frame: 1 year

how many that are cured of BV after 1 month

Secondary outcomes

Diagnosis of BV using molecular test

Time frame: 1 year

the Kappa index Hay/ison diagnosis and the molecular test

Sponsors and collaborators

Lead sponsor

Skaraborg Hospital

Other Gov

Registry information

Official study 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

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2018
First posted: Aug 15, 2019
Registry last updated: Aug 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed