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Randomized, Double-Blind Placebo-Controlled Trial to Assess Overall User Experience of a Synbiotic Vaginal Suppository

NCT06236893 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-05-31

No results posted yet for this study

Summary

The purpose of this study is to assess the impact of a personal care product on vaginal health in individuals with a self-reported history of vaginal discomforts such as malodor, bothersome discharge, itching, irritation, and dryness. The personal care product, VH-01 contains a prebiotic and three distinct strains of Lactobacillus crispatus, a microbe commonly found in healthy vaginal microbiomes. The study will be a randomized, placebo-controlled trial where the test product will be compared to a placebo in a 2:1 manner. Participants will be asked to complete online questionnaires and provide vaginal samples to assess microbial communities.

The aims of this study are to assess:

1. The user experience and acceptability of VH-01 vaginal suppository vs. placebo.
2. Attitudes and perceptions of VH-01 vaginal suppository usage vs. placebo.
3. Health-related quality of life during the use of VH-01 vaginal suppository vs. placebo.
4. Changes in self-perceived vaginal discomforts during the use of VH-01 vaginal suppository vs. placebo.

Conditions

  • Vaginal Personal Care

Interventions

OTHER

VH-01 vaginal suppository tablet

Participants will be instructed to take VH-01 Days 1, 4, 7, 14, and 21 of Month 1 and Days 1 and 14 of Months 2 and 3.

OTHER

Placebo vaginal suppository tablet

Participants will be instructed to take the placebo on Days 1, 4, 7, 14, and 21 of Month 1 and Days 1 and 14 of Months 2 and 3.

Sponsors & Collaborators

  • Seed Health

    lead INDUSTRY

Principal Investigators

  • Dirk Gevers, PhD

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-29
Primary Completion
2024-07-31
Completion
2024-07-31

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 NCT06236893 on ClinicalTrials.gov