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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

Study Summary

This trial is testing whether the Flourish HEC Vaginal Care System can prevent recurrent bacterial vaginosis in women with heightened vulvovaginal sensitivity and a history of BV.

Eligible Conditions

Bacterial Vaginosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months to 6 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

BV recurrence

Change in vaginal microbiome by Nugent scoring

Change in vaginal microbiome by next-generation sequencing (NGS)

Secondary outcome measures

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Center for Pelvic HealthOTHER

Vaginal Biome ScienceLead Sponsor

8 Previous Clinical Trials

168 Total Patients Enrolled

Sexual Health and Wellness InstituteLead Sponsor

8 Previous Clinical Trials

168 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What qualifications do individuals need to fulfill in order to participate in this research?

"Eligibility criteria for this trial include vaginosis, bacterial infection and an age between 18 to 52. The maximum number of patients that can be accepted is 20."

Answered by AI

Does the current protocol of this trial permit the inclusion of participants under 40 years?

"The criteria for admission to this medical trial necessitates that the patient is between 18 and 52 years of age. Alternative studies exist wherein participants are either younger than 18 or over 65."

Answered by AI

Are there still openings to join this research study?

"According to the clinicaltrials.gov listing, recruitment for this trial is not actively happening; it was first posted on December 22nd 2021 and most recently updated on May 18th 2022. On the other hand, 15 other trials are presently searching for participants at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Flourish HEC to Prevent Recurrence of BV

2021. "Flourish HEC to Prevent Recurrence of BV". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05386147.