Vaginal HealthNCT07435350
A Trial to Assess the Pharmacokinetics and Pharmacodynamics of a Novel Synbiotic Oral Supplement for Vaginal Health
A study testing Vaginal Health Active VV-01 in people with Vaginal Health, run by Radicle Science at 1 site in United States.
Trial summary
A randomized, placebo-controlled trial to assess the Pharmacokinetics and Pharmacodynamics of a novel synbiotic dietary supplement for vaginal health. Read more about this study
- Who is it for?
- Ages 21 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Health
- What is being tested?
- Vaginal Health Active VV-01
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2026to 4 Jul 2026
- 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 21 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must meet all the following criteria:
- Healthy women with a vagina 21 - 60 years old at the time of electronic consent
- Sex assigned female at birth
- Eligible menstrual status:
- Pre-menopausal is defined as women in their childbearing years who must have a regular menstrual cycle (consistently average cycle length of 21 to 35 days) Note: Women in their childbearing years who do not have a regular menstrual cycle due to a hormone-based intrauterine device are eligible
- Peri-menopausal is defined as women who report irregular periods (differences in menstruation compared with their typical cycle in their 20s), with at least 1 period in the last 12 months AND report mild menopausal symptoms (e.g., vasomotor symptoms such as hot flashes, night sweats)
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- Post-menopausal is defined as women with an absence of menstrual cycle for the last 12 consecutive months or longer
- Willing to ingest an oral capsule during the study and be blinded to product identity (active or placebo)
- Willing to self-collect vaginal swabs and pH samples
- Willing to abstain from the use of intravaginal products during the study period (e.g., vaginal suppositories, vaginal moisturizers including hyaluronic acid, boric acid suppositories, pH balancing wipes, douching, vaginal creams/gels), as well as lubrication and spermicides
- Able to read and comprehend English and provide electronic informed consent
- Resides in the United States
Who cannot join
- Active vaginal, pelvic, or urogenital infection (e.g., UTI, BV, yeast infection)
- Chronic vulvar and vaginal conditions (e.g., vulvodynia, lichen sclerosis and lichen planus, desquamative inflammatory vaginitis)
- Unexplained vaginal bleeding
- Use of copper-based intrauterine devices
- Note: Hormone-based intrauterine devices are permitted (e.g., Mirena®)
- For peri-menopausal and post-menopausal individuals, use of estrogen-based vaginal cream/gel or suppositories
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- Women who have undergone surgical menopause (e.g., bilateral oophorectomy with or without hysterectomy)
- Current or recent use (< 3 months prior to enrollment) of antibiotics or antifungals, or anticipated use during study period (e.g., perioperative antibiotics for upcoming elective procedures)
- Current or recent use (<4 weeks prior to enrollment) of any other probiotic, prebiotic or synbiotic-containing products
- Note: Individuals who undergo a washout of 4-weeks prior to enrollment and are willing to abstain from consuming such products during the study are permitted. Food-based probiotics, prebiotics, and synbiotics are permitted (e.g., kimchi, yoghurt, kefir, kombucha)
- Pregnant, breastfeeding, or actively trying to conceive during the study period.
- Allergy to any ingredients in the investigational or placebo product.
- Receiving chronic oral steroid therapy (excluding those for skin, eyes, nose, or inhaled) or have received such treatment within 4 weeks of enrollment
- Surgery, immunotherapy, chemotherapy, radiation, or biological cancer therapy within 4 weeks of enrollment and/or planned during the next 2 weeks
- Diagnosed and active serious medical condition requiring current treatment (e.g., cancer; autoimmune diseases [lupus, rheumatoid arthritis, Crohn's disease]; serious cardiac, liver, endocrine (insulin-dependent diabetes and/or on SGLT2 inhibitors such as Jardiance®/Empagliflozin, Farxiga®/Dapagliflozin) or kidney disease; psychiatric conditions / substance use disorders; chronic infections [HIV, Hepatitis B/C], any condition which in the investigator's opinion may jeopardize the individual's safety or interfere with the ability to comply with the study
- Participation in another clinical trial within 90 days of screening
- International travel during the study period
Trial locations and contacts
1 site in 1 country.
United States1 site
Radicle Science Inc.
Del Mar, California, 92014-2605
About this study
Official title: A Randomized, Placebo-Controlled Trial to Assess the Pharmacokinetics and Pharmacodynamics of a Novel Synbiotic Oral Supplement for Vaginal Health
A randomized, placebo-controlled trial to assess the Pharmacokinetics and Pharmacodynamics of a novel synbiotic dietary supplement for vaginal health.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, decentralized clinical trial that will enroll approximately 200 healthy women aged 21-60 years old who meet all eligibility criteria. Eligible participants will be stratified based on key factors.
Following stratification, participants will be randomized to one of the study arms (placebo or VV-01 product) using block randomization. Participants will have a 1:1 chance of receiving the active study product or the placebo.
Participants will receive study kits containing the study product, administration supplies, biomarker self-collection materials, and comprehensive instructions for product use and sample collection.
The duration of the study for each participant will be approximately 2 weeks following enrollment.
- Conditions
- Vaginal Health
- Being tested
- Vaginal Health Placebo Control, Vaginal Health Active VV-01
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal Health Placebo ControlDietary supplement
Vaginal Health Placebo Control Participants will orally ingest Vaginal Health Placebo Control once daily as directed for a period of 2 weeks
Vaginal Health Active VV-01Dietary supplement
Product 1 Participants will orally ingest Vaginal Health Active Product 1 once daily as directed for a period of 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Active VV-01 | Active comparator | Vaginal Health Active VV-01 Receives: Dietary Supplement: Vaginal Health Active VV-01 |
| Placebo Control | Placebo comparator | Vaginal Health Placebo Control Receives: Dietary Supplement: Vaginal Health Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonization of VV-01 probiotic strains in the vagina
Colonization of VV-01 probiotic strains in the vagina assessed using strain-specific qPCR from vaginal swabs
Measured: Baseline to Day 14
Secondary outcomes (3)
Vaginal microbial ecosystem structure
Structure of the vaginal microbiome assessed by metagenomic sequencing of vaginal swabs
Measured: Baseline to Day 14
Biogenic amines production capability in the vaginal microbiome
Biogenic amines production capability assessed by metagenomic sequencing (functional genomics) of vaginal swabs
Measured: Baseline to Day 14
Safety and tolerability
Safety and tolerability assessed through observation of serious adverse events
Measured: Baseline to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start26 Feb 2026
- Primary completion4 Jul 2026
- Study completion4 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal HealthStudies of the same condition, open and under way.
- More trials run by Radicle ScienceThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment. Participants will be sequentially randomized to one of two study groups, with an equal (1:1) chance of receiving the study product or placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radicle Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susan Hewlings, Principal investigator, Radicle Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435350
- Sponsor's protocol ID
- RADX_C026_DSH
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared with researchers outside of Radicle Collaborators on this study.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled Trial to Assess the Pharmacokinetics and Pharmacodynamics of a Novel Synbiotic Oral Supplement for Vaginal Health
- ClinicalTrials.gov ID
- NCT07435350
- Acronym / sponsor ID
- RADX_C026_DSH
- Conditions
- Vaginal Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Radicle ScienceIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2026 (actual)
- Primary completion
- 4 Jul 2026 (actual)
- Study completion
- 4 Jul 2026 (actual)
- First posted
- 27 Feb 2026 (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.
A randomized, placebo-controlled trial to assess the Pharmacokinetics and Pharmacodynamics of a novel synbiotic dietary supplement for vaginal health.
Detailed description
This is a randomized, double-blind, placebo-controlled, decentralized clinical trial that will enroll approximately 200 healthy women aged 21-60 years old who meet all eligibility criteria. Eligible participants will be stratified based on key factors.
Following stratification, participants will be randomized to one of the study arms (placebo or VV-01 product) using block randomization. Participants will have a 1:1 chance of receiving the active study product or the placebo.
Participants will receive study kits containing the study product, administration supplies, biomarker self-collection materials, and comprehensive instructions for product use and sample collection.
The duration of the study for each participant will be approximately 2 weeks following enrollment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Parallel Assignment. Participants will be sequentially randomized to one of two study groups, with an equal (1:1) chance of receiving the study product or placebo
| Arm | Type | Receives |
|---|---|---|
| Active VV-01 | Active comparator | Dietary Supplement: Vaginal Health Active VV-01Vaginal Health Active VV-01 |
| Placebo Control | Placebo comparator | Dietary Supplement: Vaginal Health Placebo ControlVaginal Health Placebo Control |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Healthy women with a vagina 21 - 60 years old at the time of electronic consent
- Sex assigned female at birth
- Eligible menstrual status:
- Willing to ingest an oral capsule during the study and be blinded to product identity (active or placebo)
- Willing to self-collect vaginal swabs and pH samples
Key exclusion criteria (17 listed)
- Active vaginal, pelvic, or urogenital infection (e.g., UTI, BV, yeast infection)
- Chronic vulvar and vaginal conditions (e.g., vulvodynia, lichen sclerosis and lichen planus, desquamative inflammatory vaginitis)
- Unexplained vaginal bleeding
- Use of copper-based intrauterine devices
- For peri-menopausal and post-menopausal individuals, use of estrogen-based vaginal cream/gel or suppositories
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 |
|---|---|---|
| Vaginal Health Placebo ControlVaginal Health Placebo Control Participants will orally ingest Vaginal Health Placebo Control once daily as directed for a period of 2 weeks | Dietary supplement | Placebo Control |
| Vaginal Health Active VV-01Product 1 Participants will orally ingest Vaginal Health Active Product 1 once daily as directed for a period of 2 weeks. | Dietary supplement | Active VV-01 |
Primary outcome
Colonization of VV-01 probiotic strains in the vagina
Time frame: Baseline to Day 14
Colonization of VV-01 probiotic strains in the vagina assessed using strain-specific qPCR from vaginal swabs
3 secondary outcomes
Vaginal microbial ecosystem structure
Time frame: Baseline to Day 14
Biogenic amines production capability in the vaginal microbiome
Time frame: Baseline to Day 14
Safety and tolerability
Time frame: Baseline to Day 14
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 14 Oct 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data will not be shared with researchers outside of Radicle Collaborators on this study.
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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.
Susan Hewlings principal investigator
Radicle Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal Health Active VV-01 in people with Vaginal Health, run by Radicle Science 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 12 inclusion and 17 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 14 Oct 2026. 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?
Colonization of VV-01 probiotic strains in the vagina (time frame: Baseline to Day 14). 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 14 Oct 2026.