Women's Health Formulation's Impact on Vaginal Health and Microbial Community
This study examines how Women's Health Formulation impacts vaginal health and its microbial community in women.
Active Product
Other Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.500 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy 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