A Study Assessing the Impact of a Women's Health Formulation on Vaginal Health and the Microbial Community

NCT07036666 | Completed

• 1 other identifier: RADX-C003-N
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

An open label study assessing the impact of a women's health formulation on vaginal health and the microbial community

Conditions

Women's Health

Outcome Measures

Primary Outcomes (1)

• 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)

  5 weeks

Secondary Outcomes (8)

• Change in Digestion-related Quality of Life (DQLQ)

  5 weeks

• Change in Overall Health Profile

  5 weeks

• Minimal Clinical Importance Difference (MCID) in Vaginal Health

  5 weeks

• Minimal Clinical Importance Difference (MCID) in Digestion-related Quality of Life (DQLQ)

  5 weeks

• Minimal Clinical Importance Difference (MCID) in Overall Health Profile

  5 weeks

Study Arms (1)

Active Product

EXPERIMENTAL

Women's (vaginal) health active product

Dietary Supplement: Active Product

Interventions

Active Product DIETARY_SUPPLEMENT

Women's (vaginal) Health Active Product

Active Product

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Radicle Science: lead

Study Sites (1)

Radicle Science, Inc

Del Mar, California, 92014-2605, United States

Location

Related Links

• Radicle Science, Inc

Study Officials

• Susan Hewlings

  Radicle Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single arm, 5-week (4 week product consumption), open label trial

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: June 25, 2025
• Study Start: July 8, 2025
• Primary Completion: October 2, 2025
• Study Completion: October 2, 2025
• Last Updated: November 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)