Effect of Flourish HEC Vaginal Care System on BV Recurrence and the Vaginal Microbiome
Completed · Not applicable
Conditions studied: Bacterial Vaginosis
In brief
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.
Key facts
- Study ID
- NCT05701722
- Run by
- Vaginal Biome Science
- People needed
- 7
- Starts
- 2023-03-29
- Expected to finish
- 2024-02-15
- Last updated by the study team
- 2024-03-07
Who can join
Age: 18 and older, up to 52. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Cis-gender women between ages 18 and 52
- Premenopausal
- Clinically diagnosed with BV twice in the past six months or three times within the past year (by provider-determined criteria)
You may not qualify if…
- Known allergies or sensitivities to any ingredients of the Flourish HEC Vaginal Care System
- Immunosuppressed or otherwise immunocompromised
- Vaginal infection at the start of the study other than bacterial vaginosis or yeast infection (these may be treated prior to starting the protocol)
- Recent (within past 3 months) use of any antibiotics except for treating BV
- Surgery within the past 3 months
- Pregnant or trying to conceive during the trial
- Lactating women
- Recent (within past 3 months) usage of any Good Clean Love® (GCL) products
- Sexual trauma history causing psychiatric or mental health disorders which may be triggered by questions related to vulvar or vaginal health, by pelvic exams, or self-application of vaginal products
Where it is running
- Haven Center for Sexual Medicine & Vulvovaginal Disorders — Tulsa, Oklahoma, United States
Full record on ClinicalTrials.gov
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