Completed

Women's Health Formulation's Impact on Vaginal Health and Microbial Community

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Study Aim

This study examines how Women's Health Formulation impacts vaginal health and its microbial community in women.

What is being tested

Active Product

Dietary Supplement
Who is being recruted

From 21 to 65 Years
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: July 2025
See protocol details

Summary

Principal SponsorRadicle Science
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: July 8, 2025

Actual date on which the first participant was enrolled.

This study aims to evaluate how a specific women's health supplement affects vaginal health and the community of microbes in the vagina. It is designed for adult participants who were assigned female at birth and reside in the United States. The study seeks participants who wish to improve their vaginal health by at least 30%. Individuals with certain health conditions like heart, liver, or kidney diseases, or those on medications that might interfere with the study, are not eligible to participate. This research is important as it could provide insights into enhancing vaginal health, addressing a common concern among many women. Participants will use the study product and report their health experiences electronically over five weeks. They will provide self-reported data at the start, during, and at the end of the study. The study is fully conducted online, so there are no in-person visits required. This setup allows for a real-world evaluation of the product's effects without the need for participants to travel or adjust their daily routines significantly. The study will monitor any changes in vaginal health indicators to understand the potential benefits of the formulation.

Official TitleAn Open Label Study Assessing the Impact of a Women's Health Formulation on Vaginal Health and the Microbial Community 
NCT07036666
Principal SponsorRadicle Science
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

500 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 21 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Women's (vaginal) health active product

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Radicle Science, Inc

Del Mar, United StatesSee the location
CompletedOne Study Center