Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 1:17 AM
NCT ID:
NCT06236893
Eligibility Criteria:
Inclusion Criteria:
* Individuals with a vagina 18 - 55 years old at time of electronic consent
* Sex assigned female at birth
* Self-reported history of any of the following vaginal discomforts occurring recently and regularly, including but not limited to: Vaginal malodor, Bothersome vaginal discharge, Vaginal itching, Vaginal irritation, Vaginal dryness
* Willing to use an intra-vaginal suppository during the study and not knowing the product identity (active or placebo)
* Willing to complete questionnaires, which include questions related to vaginal health and sexual history/behavior
* Able to read and comprehend English and provide written informed consent
* Have reliable access to the internet
Exclusion Criteria:
* In menopause or experiencing menopausal symptoms
* History of irregular menses; defined as less than 25 day or more than 35 day cycle or length of time between cycles varies by more than 9 days
* Planned insertion or replacement of IUD in next 3 months (if applicable)
* Active pelvic or vaginal infection (i.e., active urinary tract infection, active bacterial vaginosis, active yeast infection). NOTE: Eligible to re-screen 4 weeks after completion of treatment for an active infection.
* Current or anticipated oral or vaginal antibiotic/antifungal treatment in the next 3 months (e.g., preoperative antibiotics for upcoming elective procedure). NOTE: Eligible to re-screen 4-weeks after completion of treatment
* Unwilling to discontinue the use of specified intra-vaginal products during the study including the following: vaginal probiotic suppositories, vaginal moisturizers, boric acid suppositories, pH balancing wipes, intravaginal gel, external vaginal itch relief cream, odor control sprays, vaginal steam products, vaginal cleansing douche, feminine/vaginal cleanser, vaginal preventive deodorant, gel/cream treatments for feminine odor
* Orally administered probiotics for vaginal health. NOTE: Oral probiotics for non-vaginal conditions (e.g., gastrointestinal health) are permitted. Eligible to re-screen 1-week after discontinuing orally administered probiotics for vaginal health
* Pregnant, breastfeeding or trying to conceive during the course of the study
* Active abnormal uterine/vaginal bleeding
* Receiving chronic oral steroid therapy (excluding those for skin, eyes, nose, or inhaled) or have received such therapy within 4 weeks of screening
* Surgery, immunotherapy, chemotherapy, radiation or biological cancer therapy within 30 days of enrollment and/or planned during the next 3 months
* Allergy to any components of the supporting or excipient ingredients in test formulation tablets/placebo
* Active serious medical condition requiring current treatment including but not limited to: Cancer, Autoimmune diseases (lupus, rheumatoid arthritis, Crohn's disease), Chronic infections (e.g., HIV, Hepatitis B, Hepatitis C), Serious cardiac, liver, or kidney disease, Psychiatric conditions/substance use disorders,
* Any condition which in the investigator's opinion may jeopardize the individual's safety or interfere with the ability to comply with the study
* Lives in the state of Alaska, Louisiana, New Jersey or New York
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06236893
Study Brief:
Protocol Section:
NCT06236893