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Active Not Recruiting NCT05659745

Randomized, Double-blind, Placebo-controlled Trial Investigating the Role of a Personal Care Product on Vaginal Health

Conditions: Vaginal Personal Care

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 80
Sponsor: Seed Health

Location: United States

Summary

The goal of this clinical trial is to assess the impact of a personal care product on vaginal health in a healthy participant population. The personal care product, VM-02, contains a prebiotic, postbiotic, and three distinct strains of Lactobacillus crispatus, a microbe commonly found in healthy females, together accounting for greater than 85% of known genes in this species. The intervention will be compared to a placebo intervention and will aim to assess the following in a healthy female population:Measure changes in the relative and absolute abundance of a bacterial species, Lactobacillus crispatus, in the vagina, compared the baseline (prior to use of the personal care product) to two time points after use.Observe changes in vaginal pH and self-reported discomfort from vaginal odor, compared the baseline to two time points after use.Determine the user experience of three variations of a personal care product administered in different formats to improve vaginal health and establish tolerability and user acceptability.Participants will use the personal care product according to a specific program as directed, conduct vaginal swab sampling, and answer questionnaires, each at eight time points.

Eligibility Criteria

Inclusion Criteria:Reproductive age women aged ≥ 18.History of regular menses every 21-35 days for six months prior to the study.Agreement not to use specified intra-vaginal products during the study product use.Willing to use an intra-vaginal suppository or dietary supplement during the study period.Willing to complete vaginal swabs on themselves as directed in the study.Ability to understand and read English and provide written consent.Exclusion Criteria:Pregnancy or planned pregnancy in the next 6 months.Two or more amenorrheic months in the past 6 months.Lives in the state of New York.Allergy to any components of the supporting or excipient ingredients in test formulation capsules, tablets, placebos or over-the-counter competitor product.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05659745). StuddyBuddy aggregates publicly available trial information.