A Study Assessing the Impact of a Women's Health Formulation on Vaginal Health and the Microbial Community
Completed · Not applicable
Conditions studied: Women's Health
In brief
An open label study assessing the impact of a women's health formulation on vaginal health and the microbial community
Key facts
- Study ID
- NCT07036666
- Run by
- Radicle Science
- People needed
- 500
- Starts
- 2025-07-08
- Expected to finish
- 2025-10-02
- Last updated by the study team
- 2025-11-03
Who can join
Age: 21 and older, up to 65. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
- 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
Where it is running
- Radicle Science, Inc — Del Mar, California, United States
Full record on ClinicalTrials.gov
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