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Effect of Flourish HEC Vaginal Care System on BV Recurrence and the Vaginal Microbiome

NCT05701722 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2024-03-07

No results posted yet for this study

Summary

The goal of this clinical trial is to learn about the vaginal microbiome in premenopausal women with recurrent bacterial vaginosis (BV). The main questions it aims to answer are:

* Does using a specific vaginal care system reduce recurrence of BV?
* How does using this vaginal care system change the vaginal microbiome and pH over time?

Participants will:

* Have their vaginal microbiome and pH tested in several ways at three timepoints: the start of the study, 12 weeks later, and 24 weeks after the start of the study
* Answer questionnaires about vulvovaginal symptoms at each of these three timepoints
* Use a specific vaginal care system at home for 24 weeks, consisting of an intimate wash, a vaginal moisturizing gel, and a vaginal probiotic suppository, if assigned to the intervention group

Researchers will compare the group using the vaginal care system with a control group that does not use the system to see if using the system reduces risk of BV recurrence or changes the vaginal microbiome, pH, or symptoms.

Conditions

  • Bacterial Vaginosis

Interventions

DEVICE

Flourish HEC Vaginal Care System

BioNourish, a component of the Flourish HEC system, is a class II medical device. In addition to BioNourish, the system includes Balance intimate wash and BiopHresh homeopathic vaginal suppository with probiotics. All products are available over the counter and have been on the market for several years.

Sponsors & Collaborators

  • Vaginal Biome Science

    lead OTHER

Principal Investigators

  • Corey Babb, DO · Haven Center for Sexual Medicine & Vulvovaginal Disorders

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
52 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-29
Primary Completion
2024-02-15
Completion
2024-02-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05701722 on ClinicalTrials.gov