Randomized, Double-blind, Placebo-controlled Trial Investigating the Role of a Personal Care Product on Vaginal Health
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new personal care product, VM-02, on healthy women to improve vaginal health. The product contains beneficial bacteria and compounds to balance vaginal bacteria and reduce discomfort. Researchers will observe its effects over a few months.
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.
What safety data exists for the treatment known as VM-02 or VM-02 Placebo?
The OptiMARK clinical development program provides safety data, but it does not specifically mention VM-02 or VM-02 Placebo. General safety data from phase-I studies involving healthy volunteers show that adverse events can occur with various treatments, but specific information about VM-02 is not available.12345
What data supports the effectiveness of the drug VM-02?
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