Status:
COMPLETED
Flourish HEC to Prevent Recurrence of BV
Lead Sponsor:
Vaginal Biome Science
Collaborating Sponsors:
Center for Pelvic Health
Conditions:
Bacterial Vaginosis
Eligibility:
FEMALE
18-52 years
Phase:
NA
Brief Summary
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 recurrenc...
Detailed Description
BV treated with metronidazole or clindamycin recurs within 3 months in at least 43% of women, requiring additional rounds of antibiotics. Preliminary data show that the use of a commercially available...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
December 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2022
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT05386147
Start Date
December 22 2021
End Date
November 15 2022
Last Update
March 8 2024
Active Locations (1)
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1
Center for Pelvic Medicine
Rosemont, Pennsylvania, United States, 19010