Flourish HEC to Prevent Recurrence of BV

Completed · Not applicable

Conditions studied: Bacterial Vaginosis

In brief

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.

Key facts

Study ID

NCT05386147

Run by

Vaginal Biome Science

People needed

6

Starts

2021-12-22

Expected to finish

2022-11-15

Last updated by the study team

2024-03-08

Who can join

Age: 18 and older, up to 52. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Pre-menopausal women between the ages of 18 and 52.
• Diagnosis of recurrent BV: >= 3 episodes of BV within last year, or >= 2 episodes of BV within past six months, recorded in medical record
• Desire to use personal hygiene products to avoid recurrence of BV.

You may not qualify if…

• Known allergy or sensitivity to any other ingredient in the Flourish HEC Vaginal Care System
• Immunosuppressed or immunocompromised individuals
• Known allergy or intolerability to metronidazole
• Anyone who may have mental health disorders triggered by answering questions related to vulvar or vaginal health, by pelvic exams, or self-application of vaginal products
• Known vaginal infection that is not BV or yeast infection
• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)
• Pregnant women
• Prisoners

Where it is running

• Center for Pelvic Medicine — Rosemont, Pennsylvania, United States

Full record on ClinicalTrials.gov

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