Vaginal Suppository Capsule Active for Vaginal Hygiene

Study 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.

Treatment Effectiveness

Study Objectives

Trial Safety

Trial Design

Trial Logistics

Eligibility Criteria