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

NCT05659745 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2023-05-31

No results posted yet for this 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.

Conditions

  • Vaginal Personal Care

Interventions

OTHER

VM-02

VM-02 is a personal care product for vaginal health.

DIETARY_SUPPLEMENT

Commercial Oral Probiotic Competitor

Commercial Oral Vaginal Probiotic Competitor is a personal care product for vaginal health.

OTHER

VM-02 Placebo

VM-02 Placebo is a personal care product placebo for vaginal health.

Sponsors & Collaborators

  • Seed Health

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-05
Primary Completion
2023-05-15
Completion
2023-05-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05659745 on ClinicalTrials.gov