Flourish HEC to Prevent Recurrence of BV

Status Completed

Clinical Trial Summary

In a population of women with heightened vulvovaginal sensitivity and recurrent bacterial vaginosis (BV), the use of the Flourish HEC Vaginal Care System is being tested for prevention of BV recurrence over six months of use.

Clinical Trial Description

BV treated with metronidazole or clindamycin recurs within 3 months in at least 43% of women, requiring additional rounds of antibiotics. Preliminary data show that the use of a commercially available 3-component kit can dramatically reduce BV recurrence over 11 weeks of use. This study tests a similar kit with one component altered - the intravaginal gel is composed of hydroxyethylcellulose rather than aloe, making it less likely to trigger reactions in women with sensitive tissues. The study will examine recurrence of BV, vaginal pH, and vulvovaginal symptoms as in the prior study, though extended to 6 months. Additionally, this study examines changes in the vaginal microbiome using targeted next-generation sequencing with the use of the Flourish HEC system. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05386147
Study type	Interventional
Source	Vaginal Biome Science
Contact
Status	Completed
Phase	N/A
Start date	December 22, 2021
Completion date	November 15, 2022

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