An Open Label Study Assessing the Impact of a Women's Health Formulation on Vaginal Health and the Microbial Community
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Change in Vaginal Health
研究概览
简要总结
An open label study assessing the impact of a women's health formulation on vaginal health and the microbial community
详细描述
This is an open label study conducted with adult participants, assigned female at birth, residing in the United States.
Eligible participants will (1) endorse a desire for better vaginal health and (2) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome.
Participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded.
Self-reported data are collected electronically from eligible participants over 5 weeks. Participant reports of health indicators will be collected at baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Vaginal Health
时间窗: 5 weeks
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)
次要结局
- Change in Digestion-related Quality of Life (DQLQ)(5 weeks)
- Change in Overall Health Profile(5 weeks)
- Change in Digestion-related Quality of Life (DQLQ)(5 weeks)
- Change in Overall Health Profile(5 weeks)
- Minimal Clinical Importance Difference (MCID) in Vaginal Health(5 weeks)
- Minimal Clinical Importance Difference (MCID) in Digestion-related Quality of Life (DQLQ)(5 weeks)
- Minimal Clinical Importance Difference (MCID) in Overall Health Profile(5 weeks)
- Vaginal Total Lactobacilli Abundance(5 weeks)
- Vaginal Community State Type (CST)(5 weeks)
- Vaginal pH(5 weeks)