Randomized, Double-Blind Placebo-Controlled Trial to Assess Overall User Experience of a Synbioti… (NCT06236893) | Clinical Trial Compass
CompletedNot Applicable
Randomized, Double-Blind Placebo-Controlled Trial to Assess Overall User Experience of a Synbiotic Vaginal Suppository
United States200 participantsStarted 2024-01-29
Plain-language summary
The purpose of this study is to assess the impact of a personal care product on vaginal health in individuals with a self-reported history of vaginal discomforts such as malodor, bothersome discharge, itching, irritation, and dryness. The personal care product, VH-01 contains a prebiotic and three distinct strains of Lactobacillus crispatus, a microbe commonly found in healthy vaginal microbiomes. The study will be a randomized, placebo-controlled trial where the test product will be compared to a placebo in a 2:1 manner. Participants will be asked to complete online questionnaires and provide vaginal samples to assess microbial communities.
The aims of this study are to assess:
1. The user experience and acceptability of VH-01 vaginal suppository vs. placebo.
2. Attitudes and perceptions of VH-01 vaginal suppository usage vs. placebo.
3. Health-related quality of life during the use of VH-01 vaginal suppository vs. placebo.
4. Changes in self-perceived vaginal discomforts during the use of VH-01 vaginal suppository vs. placebo.
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:
* Individuals with a vagina 18 - 55 years old at time of electronic consent
* Sex assigned female at birth
* Self-reported history of any of the following vaginal discomforts occurring recently and regularly, including but not limited to: Vaginal malodor, Bothersome vaginal discharge, Vaginal itching, Vaginal irritation, Vaginal dryness
* Willing to use an intra-vaginal suppository during the study and not knowing the product identity (active or placebo)
* Willing to complete questionnaires, which include questions related to vaginal health and sexual history/behavior
* Able to read and comprehend English and provide written informed consent
* Have reliable access to the internet
Exclusion Criteria:
* In menopause or experiencing menopausal symptoms
* History of irregular menses; defined as less than 25 day or more than 35 day cycle or length of time between cycles varies by more than 9 days
* Planned insertion or replacement of IUD in next 3 months (if applicable)
* Active pelvic or vaginal infection (i.e., active urinary tract infection, active bacterial vaginosis, active yeast infection). NOTE: Eligible to re-screen 4 weeks after completion of treatment for an active infection.
* Current or anticipated oral or vaginal antibiotic/antifungal treatment in the next 3 months (e.g., preoperative antibiotics for upcoming elective procedure). NOTE: Eligible to re-screen 4-weeks after completion of treatment
* Unwilling to discontinue the use of specified int…
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
To evaluate user experience of VH-01 vaginal suppository vs. placebo.
Timeframe: From enrollment through three complete menstrual cycles or approximately 3 months.