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VH-01 vaginal suppository tablet for Vaginal Hygiene

N/A

Waitlist Available

Research Sponsored by Seed Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Sex assigned female at birth

Individuals with a vagina 18 - 55 years old at time of electronic consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment through three complete menstrual cycles or approximately 3 months.

Awards & highlights

Study Summary

This trial aims to understand how a personal care product called VS-01™ affects vaginal health in people who have experienced issues like bad odor, discharge, itching, irritation, and dryness. VS-

Who is the study for?

This trial is for individuals with a vagina, aged 18-55, who have experienced vaginal discomforts like odor, discharge, itching, irritation or dryness. Participants must be willing to use an unknown suppository (active or placebo) and complete online health questionnaires.Check my eligibility

What is being tested?

The study tests VS-01™ vaginal suppositories containing prebiotics and Lactobacillus crispatus against a placebo. The goal is to evaluate user experience, attitudes towards the product's use, quality of life impact and changes in self-perceived vaginal discomforts.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include reactions similar to the reported discomforts such as increased malodor, discharge variation or heightened irritation due to sensitivity to ingredients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was assigned female at birth.

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I am a woman aged 18-55 and have given electronic consent.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment through three complete menstrual cycles or approximately 3 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment through three complete menstrual cycles or approximately 3 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment through three complete menstrual cycles or approximately 3 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To evaluate user experience of VH-01 vaginal suppository vs. placebo.

Secondary outcome measures

To evaluate attitudes and perceptions of VH-01 vaginal suppository usage vs. placebo.

To evaluate health-related quality of life during the use of VH-01 vaginal suppository vs. placebo.

Other outcome measures

To evaluate changes in self-perceived vaginal discomforts during the use of VH-01 vaginal suppository vs. placebo.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: VH-01 vaginal suppository tabletExperimental Treatment1 Intervention

Participants will be instructed to take VH-01 vaginal suppository tablet (active product) as directed.

Group II: Placebo vaginal suppository tabletPlacebo Group1 Intervention

Participants will be instructed to take the placebo vaginal suppository tablet as directed. The placebo vaginal suppositories do not contain active ingredients and are identical in appearance to the active product.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Seed HealthLead Sponsor

4 Previous Clinical Trials

283 Total Patients Enrolled

Dirk Gevers, PhDStudy Director

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants currently being sought for enrollment in this ongoing medical study?

"Apologies for the confusion. According to the latest information on clinicaltrials.gov, this study is currently not seeking participants. It was initially posted on January 29th, 2024 and last updated on January 24th, 2024. However, it's worth noting that there are other ongoing studies available for enrollment at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Randomized, Double-Blind Placebo-Controlled Trial to Assess Overall User Experience of a Synbiotic Vaginal Suppository

2024. "Randomized, Double-Blind Placebo-Controlled Trial to Assess Overall User Experience of a Synbiotic Vaginal Suppository". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06236893.