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Device

Flourish HEC Vaginal Care System (contains a class II medical device plus other unregulated components) for Bacterial Vaginosis

N/A
Waitlist Available
Led By Susan Kellogg-Spadt, PhD, CRNP
Research Sponsored by Vaginal Biome Science
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months to 6 months
Awards & highlights

Summary

This trial tests a special kit called the Flourish HEC Vaginal Care System to help women with sensitive tissues and recurring bacterial infections. The kit includes a gentle gel that helps keep the vaginal environment stable and less prone to infections.

Eligible Conditions
  • Bacterial Vaginosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
BV recurrence
Change in vaginal microbiome by Nugent scoring
Change in vaginal microbiome by next-generation sequencing (NGS)
Secondary study objectives
Change in vaginal pH
Change in vulvovaginal symptoms questionnaire (VSQ) self-report

Trial Design

1Treatment groups
Experimental Treatment
Group I: Study groupExperimental Treatment1 Intervention
Women with recurrent BV use the Flourish HEC Vaginal Care System, consisting of three components: 1) "Balance" external wash; 2) BioNourish vaginal moisturizing gel (an FDA 510k cleared class II medical device); and 3) BiopHresh homeopathic vaginal suppository with probiotics. All system components are currently available to the public at national retailers. Women will use the system for six months. They will have vaginal microbiome composition (next-generation sequencing and Nugent score) and vaginal pH tested at baseline, 3 months, and 6 months. At each timepoint they will also complete the vulvovaginal symptoms questionnaire (VSQ).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Flourish HEC Vaginal Care System (contains a class II medical device plus other unregulated components)
2021
N/A
~10

Find a Location

Who is running the clinical trial?

Vaginal Biome ScienceLead Sponsor
9 Previous Clinical Trials
3,418 Total Patients Enrolled
Center for Pelvic HealthOTHER
Sexual Health and Wellness InstituteLead Sponsor
8 Previous Clinical Trials
168 Total Patients Enrolled
~2 spots leftby Sep 2025
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