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Not Yet Recruiting NCT05701722

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

Conditions: Bacterial Vaginosis

Sex: Female
Ages: 18 Years – 52 Years
Phase: NA
Enrollment: 400
Sponsor: Sexual Health and Wellness Institute

Location: United States

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 studyAnswer questionnaires about vulvovaginal symptoms at each of these three timepointsUse 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 groupResearchers 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.

Eligibility Criteria

Inclusion Criteria:Cis-gender women between ages 18 and 52PremenopausalClinically diagnosed with BV twice in the past six months or three times within the past year (by provider-determined criteria)Exclusion Criteria:Known allergies or sensitivities to any ingredients of the Flourish HEC Vaginal Care SystemImmunosuppressed or otherwise immunocompromisedVaginal 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 BVSurgery within the past 3 monthsPregnant or trying to conceive during the trialLactating womenRecent (within past 3 months) usage of any Good Clean Love® (GCL) productsSexual 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05701722). StuddyBuddy aggregates publicly available trial information.