Women's HealthNCT07036666
A Study Assessing the Impact of a Women's Health Formulation on Vaginal Health and the Microbial Community
A study testing Active Product in people with Women's Health, run by Radicle Science at 1 site in United States.
Trial summary
An open label study assessing the impact of a women's health formulation on vaginal health and the microbial community Read more about this study
- Who is it for?
- Ages 21 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Women's Health
- What is being tested?
- Active Product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2025to 2 Oct 2025
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must meet all the following criteria:
- Adults, assigned female at birth, 21-65 years of age at the time of electronic consent, inclusive of all ethnicities, races
- Resides in the United States
- Endorses better vaginal health as a primary desire
- Has the opportunity for at least 30% improvement in their primary health outcome (i.e., Vaginal Health Survey score ≥ 14 at screening)
- Willingness to complete a vaginal biospecimen at 2 timepoints
Who cannot join
- Individuals who report any of the following during screening will be excluded from participation:
- Report being pregnant, trying to become pregnant, or breastfeeding
- Unable to provide a valid US shipping address and mobile phone number ● Reports current enrollment in another clinical trial
- Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
- Unable to read and understand English
- Reports a current and/or recent (up to 3 months ago) major illness and/or surgery that poses a known, significant safety risk.
Show all 14Show fewer
- Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known contraindication and/or a significant safety risk with any of the study product ingredients.
- o NYHA Class III or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure
- Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients. o Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs, or thyroid products
- Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s) that may limit the effects of the study products
- Participants must not be undergoing treatment for bacterial vaginosis (ABX) - they will be ineligible if they answer yes to antimicrobials
- Participants must not be using prescription or over- the- counter (OTC) treatments for bacterial vaginosis or yeast infections
- Participants must not be have been diagnosed with a urinary tract infection (UTI) in the past 3 months
- Lack of reliable daily access to the internet
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: An Open Label Study Assessing the Impact of a Women's Health Formulation on Vaginal Health and the Microbial Community
An open label study assessing the impact of a women's health formulation on vaginal health and the microbial community
Read the detailed description
This is an open label study conducted with adult participants, assigned female at birth, residing in the United States.
Eligible participants will (1) endorse a desire for better vaginal health and (2) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome.
Participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded.
Self-reported data are collected electronically from eligible participants over 5 weeks. Participant reports of health indicators will be collected at baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.
- Conditions
- Women's Health
- Being tested
- Active Product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active ProductDietary supplement
Women's (vaginal) Health Active Product
| Study group | Role | What they receive |
|---|---|---|
| Active Product | Experimental | Women's (vaginal) health active product Receives: Dietary Supplement: Active Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Vaginal Health
Difference between rates of change over time in vaginal health score as assessed by Vaginal Health Survey (scale 6-30; where the higher scores correspond to worse vaginal health)
Measured: 5 weeks
Secondary outcomes (8)
Change in Digestion-related Quality of Life (DQLQ)
Difference between rates of change over time in DQLQ score as assessed by Digestion-related Quality of Life survey (scale 0-9; where the higher scores correspond to worse GI-related quality of life)
Measured: 5 weeks
Change in Overall Health Profile
Difference between rates of change over time in overall health score as assessed by Patient Reported Outcome Measurement System (PROMIS) 29+2 Profile (PROPr consists of 7 health domains: physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, cognitive function abilities; PROPr t-score score range = -.022 to 1; higher scores indicate greater overall health)
Measured: 5 weeks
Minimal Clinical Importance Difference (MCID) in Vaginal Health
Likelihood of achieving a MCID in vaginal health, as measured by Vaginal Health Survey (scale 6-30; where the higher scores correspond to worse vaginal health)
Measured: 5 weeks
Minimal Clinical Importance Difference (MCID) in Digestion-related Quality of Life (DQLQ)
Likelihood of achieving a MCID in overall health, as measured by Digestion-related Quality of Life survey (scale 0-9; where the higher scores correspond to worse GI-related quality of life)
Measured: 5 weeks
Minimal Clinical Importance Difference (MCID) in Overall Health Profile
Likelihood of achieving a MCID in digestion-related quality of life, as measured by (PROMIS) 29+2 Profile (PROPr consists of 7 health domains: physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, cognitive function abilities; PROPr t-score score range = -.022 to 1; higher scores indicate greater overall health)
Measured: 5 weeks
Vaginal Total Lactobacilli Abundance
Estimate the mean change in biomarker levels from baseline
Measured: 5 weeks
Vaginal Community State Type (CST)
Estimate the mean change in biomarker levels from baseline
Measured: 5 weeks
Vaginal pH
Estimate the mean change in biomarker levels from baseline
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start8 Jul 2025
- Primary completion2 Oct 2025
- Study completion2 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women's 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, 5-week (4 week product consumption), open label trial
- Masking
- None (open label)
- Enrolment
- 500 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 Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036666
- Sponsor's protocol ID
- RADX-C003-N
- Status last verified
- Jun 2025
- First submitted
- 16 Jun 2025
- Last updated
- 3 Nov 2025
- 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 Radicle Science collaborators on this study.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study Assessing the Impact of a Women's Health Formulation on Vaginal Health and the Microbial Community
- ClinicalTrials.gov ID
- NCT07036666
- Acronym / sponsor ID
- RADX-C003-N
- Conditions
- Women's Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Radicle ScienceIndustry (pharma, biotech, devices)
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- 2 Oct 2025 (actual)
- Study completion
- 2 Oct 2025 (actual)
- First posted
- 25 Jun 2025 (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.
An open label study assessing the impact of a women's health formulation on vaginal health and the microbial community
Detailed description
This is an open label study conducted with adult participants, assigned female at birth, residing in the United States.
Eligible participants will (1) endorse a desire for better vaginal health and (2) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome.
Participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded.
Self-reported data are collected electronically from eligible participants over 5 weeks. Participant reports of health indicators will be collected at baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, 5-week (4 week product consumption), open label trial
| Arm | Type | Receives |
|---|---|---|
| Active Product | Experimental | Dietary Supplement: Active ProductWomen's (vaginal) health active product |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants must meet all the following criteria:
Key exclusion criteria (14 listed)
- Individuals who report any of the following during screening will be excluded from participation:
- o NYHA Class III or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure
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 |
|---|---|---|
| Active ProductWomen's (vaginal) Health Active Product | Dietary supplement | Active Product |
Primary outcome
Change in Vaginal Health
Time frame: 5 weeks
Difference between rates of change over time in vaginal health score as assessed by Vaginal Health Survey (scale 6-30; where the higher scores correspond to worse vaginal health)
8 secondary outcomes
Change in Digestion-related Quality of Life (DQLQ)
Time frame: 5 weeks
Change in Overall Health Profile
Time frame: 5 weeks
Minimal Clinical Importance Difference (MCID) in Vaginal Health
Time frame: 5 weeks
Minimal Clinical Importance Difference (MCID) in Digestion-related Quality of Life (DQLQ)
Time frame: 5 weeks
Minimal Clinical Importance Difference (MCID) in Overall Health Profile
Time frame: 5 weeks
Vaginal Total Lactobacilli Abundance
Time frame: 5 weeks
Vaginal Community State Type (CST)
Time frame: 5 weeks
Vaginal pH
Time frame: 5 weeks
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 3 Nov 2025.
- Radicle Science, IncLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data will not be shared with researchers outside Radicle Science 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 Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Product in people with Women's 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 6 inclusion and 14 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 3 Nov 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. 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?
Change in Vaginal Health (time frame: 5 weeks). 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 3 Nov 2025.