Vaginal Personal CareNCT06236893
Randomized, Double-Blind Placebo-Controlled Trial to Assess Overall User Experience of a Synbiotic Vaginal Suppository
A study testing VH-01 vaginal suppository tablet in people with Vaginal Personal Care, run by Seed Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaginal Personal Care
- What is being tested?
- VH-01 vaginal suppository tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2024to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 intra-vaginal products during the study including the following: vaginal probiotic suppositories, vaginal moisturizers, boric acid suppositories, pH balancing wipes, intravaginal gel, external vaginal itch relief cream, odor control sprays, vaginal steam products, vaginal cleansing douche, feminine/vaginal cleanser, vaginal preventive deodorant, gel/cream treatments for feminine odor
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- Orally administered probiotics for vaginal health. NOTE: Oral probiotics for non-vaginal conditions (e.g., gastrointestinal health) are permitted. Eligible to re-screen 1-week after discontinuing orally administered probiotics for vaginal health
- Pregnant, breastfeeding or trying to conceive during the course of the study
- Active abnormal uterine/vaginal bleeding
- Receiving chronic oral steroid therapy (excluding those for skin, eyes, nose, or inhaled) or have received such therapy within 4 weeks of screening
- Surgery, immunotherapy, chemotherapy, radiation or biological cancer therapy within 30 days of enrollment and/or planned during the next 3 months
- Allergy to any components of the supporting or excipient ingredients in test formulation tablets/placebo
- Active serious medical condition requiring current treatment including but not limited to: Cancer, Autoimmune diseases (lupus, rheumatoid arthritis, Crohn's disease), Chronic infections (e.g., HIV, Hepatitis B, Hepatitis C), Serious cardiac, liver, or kidney disease, Psychiatric conditions/substance use disorders,
- Any condition which in the investigator's opinion may jeopardize the individual's safety or interfere with the ability to comply with the study
- Lives in the state of Alaska, Louisiana, New Jersey or New York
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind Placebo-Controlled Trial to Assess The Overall User Experience of a Synbiotic Vaginal Suppository
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:
- The user experience and acceptability of VH-01 vaginal suppository vs. placebo.
- Attitudes and perceptions of VH-01 vaginal suppository usage vs. placebo.
- Health-related quality of life during the use of VH-01 vaginal suppository vs. placebo.
- Changes in self-perceived vaginal discomforts during the use of VH-01 vaginal suppository vs. placebo.
Read the detailed description
The vaginal microbiome is a community of microorganisms that live inside of the vagina. Studies have shown that vaginal microbiomes can be classified into one of five community state types (CSTs) known as: CST I, II, III, IV, and V. CSTs are determined based on the taxonomic composition of the vaginal microbiome. CST I, dominated by Lactobacillus crispatus, is considered optimal and is significantly associated with vaginal health.
Lactobacillus crispatus produces lactic acid and other compounds that maintain an optimal vaginal pH, which discourages the growth of harmful microbes that lead to disruptions in the vaginal microbial ecosystem. These disruptions may increase vaginal discomforts such as vaginal malodor, discharge, itching, irritation, and dryness.
VH-01 is a multi-strain vaginal synbiotic designed to seed and sustain an optimal and protective CST I vaginal ecology. The product delivers an ecology of complimentary Lactobacillus crispatus and synbiotic ingredients to promote an optimal vaginal ecology. The strains were selected to confer maximal vaginal microbiome stability in response to potential perturbations such as menstruation, sex, exercise, medication and other environmental influences.
The purpose of this study is to determine whether vaginal health can be influenced by a novel personal care product comprised of a prebiotic, and multiple strains of Lactobacillus crispatus associated with a stable vaginal microbiome.
- Conditions
- Vaginal Personal Care
- Being tested
- VH-01 vaginal suppository tablet, Placebo vaginal suppository tablet
- Keywords
- Lactobacillus crispatus, vaginal malodor, vaginal discharge, vaginal itching, vaginal irritation, vaginal dryness
- Medical subject headings
- Vaginal Discharge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VH-01 vaginal suppository tabletOther
Participants will be instructed to take VH-01 Days 1, 4, 7, 14, and 21 of Month 1 and Days 1 and 14 of Months 2 and 3.
Placebo vaginal suppository tabletOther
Participants will be instructed to take the placebo on Days 1, 4, 7, 14, and 21 of Month 1 and Days 1 and 14 of Months 2 and 3.
| Study group | Role | What they receive |
|---|---|---|
| VH-01 vaginal suppository tablet | Experimental | Participants will be instructed to take VH-01 vaginal suppository tablet (active product) as directed. Receives: Other: VH-01 vaginal suppository tablet |
| Placebo vaginal suppository tablet | Placebo comparator | 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. Receives: Other: Placebo vaginal suppository tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate user experience of VH-01 vaginal suppository vs. placebo.
Self-reported rate of product acceptance to support vaginal health through month 3.
Measured: From enrollment through three complete menstrual cycles or approximately 3 months.
Secondary outcomes (2)
To evaluate attitudes and perceptions of VH-01 vaginal suppository usage vs. placebo.
Self-reported change in perception of vaginal state through month 3 [5-point Likert scale].
Measured: From enrollment through three complete menstrual cycles or approximately 3 months.
To evaluate health-related quality of life during the use of VH-01 vaginal suppository vs. placebo.
Self-reported change in vaginal health-related quality of life through month 3 [5-point Likert scale].
Measured: From enrollment through three complete menstrual cycles or approximately 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start29 Jan 2024
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal Personal CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seed Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dirk Gevers, PhD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236893
- Sponsor's protocol ID
- 20260
- Status last verified
- May 2025
- First submitted
- 24 Jan 2024
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Placebo-Controlled Trial to Assess The Overall User Experience of a Synbiotic Vaginal Suppository
- ClinicalTrials.gov ID
- NCT06236893
- Acronym / sponsor ID
- 20260
- Conditions
- Vaginal Personal Care
- Keywords
- Lactobacillus crispatus, vaginal malodor, vaginal discharge, vaginal itching, vaginal irritation, vaginal dryness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Seed HealthIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The user experience and acceptability of VH-01 vaginal suppository vs. placebo.
- Attitudes and perceptions of VH-01 vaginal suppository usage vs. placebo.
- Health-related quality of life during the use of VH-01 vaginal suppository vs. placebo.
- Changes in self-perceived vaginal discomforts during the use of VH-01 vaginal suppository vs. placebo.
Detailed description
The vaginal microbiome is a community of microorganisms that live inside of the vagina. Studies have shown that vaginal microbiomes can be classified into one of five community state types (CSTs) known as: CST I, II, III, IV, and V. CSTs are determined based on the taxonomic composition of the vaginal microbiome. CST I, dominated by Lactobacillus crispatus, is considered optimal and is significantly associated with vaginal health.
Lactobacillus crispatus produces lactic acid and other compounds that maintain an optimal vaginal pH, which discourages the growth of harmful microbes that lead to disruptions in the vaginal microbial ecosystem. These disruptions may increase vaginal discomforts such as vaginal malodor, discharge, itching, irritation, and dryness.
VH-01 is a multi-strain vaginal synbiotic designed to seed and sustain an optimal and protective CST I vaginal ecology. The product delivers an ecology of complimentary Lactobacillus crispatus and synbiotic ingredients to promote an optimal vaginal ecology. The strains were selected to confer maximal vaginal microbiome stability in response to potential perturbations such as menstruation, sex, exercise, medication and other environmental influences.
The purpose of this study is to determine whether vaginal health can be influenced by a novel personal care product comprised of a prebiotic, and multiple strains of Lactobacillus crispatus associated with a stable vaginal microbiome.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VH-01 vaginal suppository tablet | Experimental | Other: VH-01 vaginal suppository tabletParticipants will be instructed to take VH-01 vaginal suppository tablet (active product) as directed. |
| Placebo vaginal suppository tablet | Placebo comparator | Other: Placebo vaginal suppository tabletParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VH-01 vaginal suppository tabletParticipants will be instructed to take VH-01 Days 1, 4, 7, 14, and 21 of Month 1 and Days 1 and 14 of Months 2 and 3. | Other | VH-01 vaginal suppository tablet |
| Placebo vaginal suppository tabletParticipants will be instructed to take the placebo on Days 1, 4, 7, 14, and 21 of Month 1 and Days 1 and 14 of Months 2 and 3. | Other | Placebo vaginal suppository tablet |
Primary outcome
To evaluate user experience of VH-01 vaginal suppository vs. placebo.
Time frame: From enrollment through three complete menstrual cycles or approximately 3 months.
Self-reported rate of product acceptance to support vaginal health through month 3.
2 secondary outcomes
To evaluate attitudes and perceptions of VH-01 vaginal suppository usage vs. placebo.
Time frame: From enrollment through three complete menstrual cycles or approximately 3 months.
To evaluate health-related quality of life during the use of VH-01 vaginal suppository vs. placebo.
Time frame: From enrollment through three complete menstrual cycles or approximately 3 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dirk Gevers, PhD study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VH-01 vaginal suppository tablet in people with Vaginal Personal Care, run by Seed Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate user experience of VH-01 vaginal suppository vs. placebo. (time frame: From enrollment through three complete menstrual cycles or approximately 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.