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Behavioural Intervention

Flourish HEC Vaginal Care System for Bacterial Vaginosis

N/A
Waitlist Available
Led By Corey Babb, DO
Research Sponsored by Sexual Health and Wellness Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Cis-gender women between ages 18 and 52
Premenopausal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 weeks, and 24 weeks will be compared using repeated measures two-way anova with study arm and time as factors.
Awards & highlights

Study Summary

This trial aims to learn if using a specific vaginal care system can reduce recurrence of BV and how it affects the vaginal microbiome and pH. Participants answer questionnaires and use the system at home for 24 weeks.

Who is the study for?
This trial is for cis-gender women aged 18-52 who have been diagnosed with recurrent bacterial vaginosis (BV) at least twice in the past six months or three times within a year and are premenopausal. It's not suitable for those who've had recent surgery, are pregnant or lactating, have used certain vaginal products recently, suffer from immune deficiencies, or could be triggered by study procedures due to sexual trauma.Check my eligibility
What is being tested?
The trial tests if the Flourish HEC Vaginal Care System can reduce BV recurrence and alter the vaginal microbiome and pH over time. Participants will use an intimate wash, moisturizing gel, and probiotic suppository for 24 weeks if assigned to the intervention group. Their outcomes will be compared with a control group not using these products.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to ingredients in the Flourish HEC Vaginal Care System. Since it involves intimate care products like washes and suppositories, there might also be risks of irritation or discomfort in the vaginal area.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a cisgender woman aged between 18 and 52.
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I have not gone through menopause.
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I have been diagnosed with bacterial vaginosis at least twice in the last 6 months or three times in the last year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 weeks, and 24 weeks will be compared using repeated measures two-way anova with study arm and time as factors.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 weeks, and 24 weeks will be compared using repeated measures two-way anova with study arm and time as factors. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recurrence of bacterial vaginosis (BV)
Secondary outcome measures
Vaginal microbiome whole-genome sequencing changes
Vaginal pH changes
Vulvovaginal symptoms by questionnaires

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Flourish HECExperimental Treatment1 Intervention
Women with recurrent BV who are randomly assigned to the Flourish HEC (intervention) arm will undergo assessments at baseline, 12 weeks, and 24 weeks. They will receive routine care as needed (see Routine Care arm). In addition, they will use the Flourish HEC Vaginal Care System regularly for the 24-week duration of the study. Briefly, they will use Balance intimate wash daily with regular bathing; BioNourish vaginal moisturizing gel every other day; and BiopHresh homeopathic vaginal suppository with probiotics every 3rd day. They will use no other products (except menstrual hygiene products) in the vulvovaginal area during the study.
Group II: Routine CareActive Control1 Intervention
Women with recurrent BV who are randomly assigned to the Routine Care (control) arm will undergo assessments at baseline, 12 weeks, and 24 weeks. They will be treated with appropriate antibiotics or antifungals in case of BV or yeast infection, respectively, but otherwise will not receive any treatment. They may engage in any vulvovaginal hygiene of their choosing except for using products made by Good Clean Love.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Flourish HEC Vaginal Care System
2023
N/A
~10

Find a Location

Who is running the clinical trial?

Sexual Health and Wellness InstituteLead Sponsor
8 Previous Clinical Trials
167 Total Patients Enrolled
Vaginal Biome ScienceUNKNOWN
8 Previous Clinical Trials
167 Total Patients Enrolled
Corey Babb, DOPrincipal InvestigatorHaven Center for Sexual Medicine & Vulvovaginal Disorders

Media Library

Flourish HEC Vaginal Care System (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05701722 — N/A
Bacterial Vaginosis Research Study Groups: Routine Care, Flourish HEC
Bacterial Vaginosis Clinical Trial 2023: Flourish HEC Vaginal Care System Highlights & Side Effects. Trial Name: NCT05701722 — N/A
Flourish HEC Vaginal Care System (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05701722 — N/A

Frequently Asked Questions

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

Is this research endeavor recruiting individuals aged 25 and older?

"To be eligible for this study, patients must fall between 18 to 52 years of age. For individuals outside that range, there are two studies targeting people younger than 18 and four exclusively for seniors over 65."

Answered by AI

Is my participation eligible for this clinical trial?

"This investigation requires 400 participants, all of whom must fit the following criteria: female gender identity, ages 18 to 52 years old, premenopausal status and two or three confirmed diagnoses of bacterial vaginosis within six months or one year."

Answered by AI

Is the opportunity to participate in this research endeavor still available?

"Unfortunately, this medical trial is no longer actively searching for potential candidates. It was initially posted on March 1st 2023, and last updated 18th of January in the same year. However, there are 17 other trials that may be a fit - patients should explore their options accordingly."

Answered by AI
~3 spots leftby Mar 2025