Randomized, Double-blind, Placebo-controlled Trial Investigating the Role of a Personal Care Prod… (NCT05659745) | Clinical Trial Compass
CompletedNot Applicable
Randomized, Double-blind, Placebo-controlled Trial Investigating the Role of a Personal Care Product on Vaginal Health
United States70 participantsStarted 2022-12-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and tolerability of VM-02 at 5 x 10^8 CFU/dose based on frequency and absolute number of patient reported adverse events
Timeframe: Throughout intervention and subsequent 4 week period following last dose