RECRUITING

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

Description

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

Conditions

Study Overview

Study Details

Study overview

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

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

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

Condition
Women's Health
Intervention / Treatment

-

Contacts and Locations

Del Mar

Radicle Science, Inc, Del Mar, California, United States, 92014-2605

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

21 Years to 65 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Radicle Science,

Susan Hewlings, PRINCIPAL_INVESTIGATOR, Radicle Science Inc.

Study Record Dates

2026-07