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NCT05659745 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Seed Health.

Completed
Registry status
NA
Development phase
70
Enrollment target

NCT05659745: Completed NA study, sponsored by Seed Health.

NCT05659745 is a NA study that has completed, run by Seed Health. The registered enrollment target is 70 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT05659745, a NA study, has completed, sponsored by Seed Health.

COMPLETED
Registry status
NA
Development phase
70 participants
Enrollment target

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.

Interventions

  • OTHER VM-02
  • DIETARY_SUPPLEMENT Commercial Oral Probiotic Competitor
  • OTHER VM-02 Placebo

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2022-12-05
Est. Completion 2023-05-15
Phase NA
Seed Health

3 total trials

What the finished NCT05659745 record still lists

NCT05659745 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 3 interventions - of which VM-02 is the first listed.

NCT05659745 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05659745 about?

NCT05659745 is a clinical study titled "Randomized, Double-blind, Placebo-controlled Trial Investigating the Role of a Personal Care Product on Vaginal Health". 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 fem...

What is the current status of trial NCT05659745?

This trial is currently completed. It is a NA study. The enrollment target is 70 participants. The study started on 2022-12-05. Estimated completion is 2023-05-15.

What interventions are being tested in trial NCT05659745?

The interventions under investigation include: VM-02 (OTHER), Commercial Oral Probiotic Competitor (DIETARY_SUPPLEMENT), VM-02 Placebo (OTHER).

Who is sponsoring clinical trial NCT05659745?

This trial is sponsored by Seed Health, which has 3 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05659745's enrollment target sits among peer trials

70 1103rd of 2000 higher than 868 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05659745, the US trial registry maintained by the National Library of Medicine. NCT05659745 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.