An open label study assessing the impact of a women's health formulation on vaginal health and the microbial community
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
500
Women's (vaginal) Health Active Product
Radicle Science, Inc
Del Mar, California, United States
Change in Vaginal Health
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)
Time frame: 5 weeks
Change in Digestion-related Quality of Life (DQLQ)
Difference between rates of change over time in DQLQ score as assessed by Digestion-related Quality of Life survey (scale 0-9; where the higher scores correspond to worse GI-related quality of life)
Time frame: 5 weeks
Change in Overall Health Profile
Difference between rates of change over time in overall health score as assessed by Patient Reported Outcome Measurement System (PROMIS) 29+2 Profile (PROPr consists of 7 health domains: physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, cognitive function abilities; PROPr t-score score range = -.022 to 1; higher scores indicate greater overall health)
Time frame: 5 weeks
Minimal Clinical Importance Difference (MCID) in Vaginal Health
Likelihood of achieving a MCID in vaginal health, as measured by Vaginal Health Survey (scale 6-30; where the higher scores correspond to worse vaginal health)
Time frame: 5 weeks
Minimal Clinical Importance Difference (MCID) in Digestion-related Quality of Life (DQLQ)
Likelihood of achieving a MCID in overall health, as measured by Digestion-related Quality of Life survey (scale 0-9; where the higher scores correspond to worse GI-related quality of life)
Time frame: 5 weeks
Minimal Clinical Importance Difference (MCID) in Overall Health Profile
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Likelihood of achieving a MCID in digestion-related quality of life, as measured by (PROMIS) 29+2 Profile (PROPr consists of 7 health domains: physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, cognitive function abilities; PROPr t-score score range = -.022 to 1; higher scores indicate greater overall health)
Time frame: 5 weeks
Vaginal Total Lactobacilli Abundance
Estimate the mean change in biomarker levels from baseline
Time frame: 5 weeks
Vaginal Community State Type (CST)
Estimate the mean change in biomarker levels from baseline
Time frame: 5 weeks
Vaginal pH
Estimate the mean change in biomarker levels from baseline
Time frame: 5 weeks