Completed

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

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Study AimThis 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

Women's Health

From 21 to 65 Years
+20 Eligibility Criteria

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: November 3, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: July 8, 2025Actual 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 
Principal SponsorRadicle Science
Last updated: November 3, 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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
From 21 to 65 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Women's Health
Criteria
6 inclusion criteria required to participate
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

Show More Criteria

14 exclusion criteria prevent from participating
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)

Show More Criteria

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

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)
Secondary Objectives

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)

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)

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)

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)

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)

Estimate the mean change in biomarker levels from baseline

Estimate the mean change in biomarker levels from baseline

Estimate the mean change in biomarker levels from baseline

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, IncDel Mar, United StatesSee the location
CompletedOne Study Center