VM-02 for Vaginal Hygiene
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how the personal care product VM-02 can enhance vaginal health by boosting beneficial bacteria. Researchers are testing various forms of the product, such as capsules and tablets, and comparing them to a placebo and a commercial competitor. They aim to determine if VM-02 can increase the presence of Lactobacillus crispatus (a beneficial bacterium) and reduce discomfort like odor. Women with regular menstrual cycles who are open to using intra-vaginal products may be suitable candidates for this trial.
As an unphased trial, this study allows participants to contribute to significant research on vaginal health and potentially benefit from innovative care solutions.
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, you must agree not to use certain intra-vaginal products during the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that VM-02, a personal care product with prebiotics, postbiotics, and specific strains of Lactobacillus crispatus, is generally safe. Previous studies examined its use as a vaginal suppository and found no major side effects. However, safety information notes that VM-02 might cause eye irritation or allergic reactions if swallowed, so careful use is important.
Lactobacillus crispatus, a type of bacteria naturally found in healthy women, adds to its safety. This bacteria helps maintain a healthy vaginal balance, supporting vaginal health and possibly preventing bacterial vaginosis or yeast infections. Although this trial phase doesn't provide detailed safety data from earlier phases, the use of naturally occurring bacteria suggests it is likely safe.
Overall, while these studies have not reported specific negative effects, the ingredients in VM-02 are generally considered safe for most people when used as directed. Participants considering joining the trial can feel reassured by the lack of significant negative reports and the product's support for natural vaginal health.12345Why are researchers excited about this trial?
Researchers are excited about these treatments for vaginal health because they're exploring new ways to maintain and improve this vital aspect of women's health. Unlike traditional oral probiotics, the VM-02 treatment includes both suppository capsules and tablets, delivering active ingredients directly to the vaginal area, which could enhance their effectiveness. This direct delivery method is unique and may offer faster and more targeted results compared to standard oral products. Additionally, the study is investigating an oral capsule version, which could provide flexibility and convenience in how the treatment is administered. By testing these varied approaches, researchers aim to find more effective and user-friendly solutions for maintaining vaginal health.
What evidence suggests that this trial's treatments could be effective for improving vaginal health?
Research has shown that probiotics containing Lactobacillus crispatus can improve vaginal health. This bacterium helps maintain a healthy microbial balance in the vagina. Studies on similar products have demonstrated positive effects, such as reducing symptoms of bacterial vaginosis, an infection caused by bacterial imbalance. In this trial, participants may receive the VM-02 product, which combines prebiotics, postbiotics, and specific strains of Lactobacillus crispatus to potentially enhance these benefits. Early findings suggest that these ingredients could increase the number of beneficial bacteria and help control vaginal pH levels, potentially reducing discomfort from odor. While direct evidence for VM-02 is still developing, its ingredients show promise for supporting vaginal health.26789
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the personal care product or placebo according to their assigned arm. The treatment involves vaginal suppository capsules, tablets, or oral capsules administered over two menstrual cycles.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments of vaginal microbiome changes and user experience.
What Are the Treatments Tested in This Trial?
Interventions
- VM-02
- VM-02 Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Seed Health
Lead Sponsor