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

Overseen By Dirk Gevers

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Seed Health

Disqualifiers: Pregnancy, Amenorrhea, New York, others

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

70 Participants Needed

Trial Summary

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 data supports the effectiveness of the drug VM-02?

The research mentions methotrexate and epirubicin, which are components of the VEM treatment used in breast cancer, showing effectiveness in downstaging tumors to allow surgery. This suggests that these components might contribute to the effectiveness of VM-02. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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.

Eligibility Criteria

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

8 weeks

8 virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of vaginal microbiome changes and user experience.

4 weeks

Treatment Details

Interventions

• VM-02
• VM-02 Placebo

Participant Groups

Group I: Vaginal Suppository Tablet Active Experimental Treatment 1 Intervention

In the VM-02 Vaginal Suppository Tablet Active Arm, participants will take a test vaginal suppository tablet as directed.

Group II: Vaginal Suppository Capsule Active Experimental Treatment 1 Intervention

In the VM-02 Vaginal Suppository Capsule Active Arm, participants will take a test vaginal suppository capsule as directed.

Group III: Oral Capsule Active Experimental Treatment 1 Intervention

In the VM-02 Oral Capsule Active Arm, participants will take a test oral capsule as directed.

Group IV: Commercial Oral Vaginal Probiotic Competitor Experimental Treatment 1 Intervention

In the Commercial Over-The-Counter (OTC) Oral Probiotic Competitor Arm, participants will take an over-the-counter competitor product as directed.

Group V: Vaginal Suppository Capsule Placebo Group 1 Intervention

In the VM-02 Vaginal Suppository Capsule Placebo Arm, participants will take the test vaginal suppository capsule placebo as directed.

Who Is Running the Clinical Trial?

Seed Health

Lead Sponsor

Trials

5

Recruited

480+

Findings from Research

Adjuvant chemotherapy significantly improves overall survival, disease-specific survival, and disease-free survival in high-risk Stage II colorectal cancer patients, with a hazard ratio of 0.61 for overall survival, based on a meta-analysis of 29 studies involving 183,749 participants.

The benefits of chemotherapy were consistent across various subgroups, including patients with multiple high-risk features and those with colon cancer, indicating that it can be an important treatment option for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative chemotherapy improves survival in patients with resected high-risk Stage II colorectal cancer: results of a systematic review and meta-analysis. Simillis, C., Singh, HKSI., Afxentiou, T., et al.[2021]

The safety of marketed drugs is a significant concern, as some commonly prescribed medications can lead to serious or life-threatening side effects in patients.

The ChEMBL resource will provide a curated drug safety data set, including toxicity classifications and black box warnings, which will be freely available and regularly updated to aid in drug safety research and discovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Safety Data Curation and Modeling in ChEMBL: Boxed Warnings and Withdrawn Drugs. Hunter, FMI., Bento, AP., Bosc, N., et al.[2023]

In a comprehensive review of 54 phase-I studies involving 1015 healthy volunteers over 10 years, the overall incidence of adverse events was found to be 12.8%, with a higher rate for active drugs (13.7%) compared to placebo (7.9%).

Most adverse events were minor, with only 3% classified as severe, and no deaths or life-threatening events reported, highlighting that while adverse events are common in phase-I trials, they are typically not serious.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in phase-I studies: a report in 1015 healthy volunteers. Sibille, M., Deigat, N., Janin, A., et al.[2019]

In a clinical development program involving 1684 subjects and 2038 injections, OptiMARK demonstrated a safety profile comparable to Magnevist, with 31% of its injections associated with adverse events.

OptiMARK was found to be safe and well-tolerated, showing fewer adverse events compared to Magnevist (35%) and placebo (48%), indicating its potential as a reliable imaging agent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The OptiMARK clinical development program: summary of safety data. Brown, JJ., Kristy, RM., Stevens, GR., et al.[2019]

A systematic review of 82 publications on the safety of rhBMP-2 for spinal fusion revealed that the most effective databases for identifying adverse effects data are the Science Citation Index (SCI) and EMBASE, both achieving a sensitivity of 62%.

To comprehensively identify all relevant studies, a combination of multiple sources including SCI, EMBASE, MEDLINE/PubMED, and additional methods like reference checking is necessary, highlighting the complexity of gathering complete safety data for medical devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The contribution of different information sources to identify adverse effects of a medical device: a case study using a systematic review of spinal fusion. Golder, S., Wright, K., Rodgers, M.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Retrospective analysis of locally advanced noninflammatory breast cancer from Chennai, South India, 1990-1999. [2007]

2. United States pubmed.ncbi.nlm.nih.gov

High rate of clinical complete response to weekly outpatient neoadjuvant chemotherapy in oral carcinoma patients using a new regimen of cisplatin, 5-fluorouracil, and bleomycin alternating with methotrexate and epirubicin. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Postoperative chemotherapy improves survival in patients with resected high-risk Stage II colorectal cancer: results of a systematic review and meta-analysis. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Vinorelbine, epirubicin, and methotrexate (VEM) as primary treatment in locally advanced breast cancer. [2019]

5. Cyprus pubmed.ncbi.nlm.nih.gov

Evaluation of the efficacy of adjuvant chemotherapy in patients with high-risk stage II colon cancer. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Drug Safety Data Curation and Modeling in ChEMBL: Boxed Warnings and Withdrawn Drugs. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Adverse events in phase-I studies: a report in 1015 healthy volunteers. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

The OptiMARK clinical development program: summary of safety data. [2019]

9. England pubmed.ncbi.nlm.nih.gov

The contribution of different information sources to identify adverse effects of a medical device: a case study using a systematic review of spinal fusion. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Descriptive epidemiology of adverse events after immunization: reports to the Vaccine Adverse Event Reporting System (VAERS), 1991-1994. [2019]