COMPLETED

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-07-08

Study Completion:2025-10-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT07036666

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 65 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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. * 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

Inclusion Criteria

Exclusion 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

* 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.
* 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

Contacts and Locations

Principal Investigator

Susan Hewlings

PRINCIPAL_INVESTIGATOR

Radicle Science Inc.

Study Locations (Sites)

Radicle Science, Inc

Del Mar, California, 92014-2605

United States

Collaborators and Investigators

Sponsor: Radicle Science

Susan Hewlings, PRINCIPAL_INVESTIGATOR, Radicle Science Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-08

Study Completion Date2025-10-02

Study Record Updates

Study Start Date2025-07-08

Study Completion Date2025-10-02

Terms related to this study

Additional Relevant MeSH Terms

Women's Health