Radicle Women's Sexual Health™ CIX: A randomized, double-blind, placebo-controlled direct-to-consumer study assessing the impact of health and wellness products on sexual health and related health outcomes.
Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities
Assigned sex at birth is female
Resides in the United States
Has the opportunity for at least 30% improvement in their primary health outcome
None
Parallel
Active Sexual Health Product 1
Dietary supplementParticipants will use their Active Sexual Health Product 1 as directed for a period of 12 weeks
Active Sexual Health Product 2
Dietary supplementParticipants will use their Active Sexual Health Product 2 as directed for a period of 12 weeks
Active Sexual Health Product 3
Dietary supplementParticipants will use their Active Sexual Health Product 3 as directed for a period of 12 weeks
Placebo Sexual Health Control Product
Dietary supplementParticipants will use their Placebo Sexual Health Control Product as directed for a period of 12 weeks
Sexual Desire
Sexual desire assessed by a single self report item, indicating sexual desire in the past 7 days. Scale 1-7 with higher scores indication greater desire.
Sexual activity frequency
Sexual activity frequency assessed by a single self-report item, indicating frequency of sexual activity in the last 7 days. Numerical text box entry, with higher scores indicating greater frequency of sexual activity.
Sexual discomfort intensity
Sexual discomfort intensity assessed by a single self-report item, indicating the intensity of discomfort during sexual activity in the past 7 days. Scale 1-7, with higher scores indicating greater sexual discomfort.
Change in feelings of stress
Change in feelings of stress: Difference between rates of change over time in feelings of stress score as assessed Perceived Stress Scale 10 (PSS-10) (score 10-50; where lower scores correspond to less stress)
Change in sleep-related impairment
Change in sleep-related impairment: Difference between rates of change over time in sleep score as assessed by PROMIS Sleep-Related Impairment 8a (score 8-40; where the higher scores correspond to worse sleep)
Minimal clinically important difference (MCID) in mood (emotional distress-depression)
Minimal clinically important difference (MCID) in mood (emotional distress-depression): Likelihood of experiencing minimal clinically important difference in mood score as assessed by PROMIS Emotional Distress- Depression 8A (score 8-40; with higher scores corresponding to greater levels of emotional distress)
Minimal clinically important difference (MCID) in sleep
Minimal clinically important difference (MCID) in sleep: Likelihood of experiencing minimal clinically important difference in sleep score, as measured by PROMIS Sleep-Related Impairment 8a (score 8-40; where the higher scores correspond to worse sleep)
Minimal clinically important difference (MCID) in feelings of stress
Minimal clinically important difference (MCID) in feelings of stress: Likelihood of experiencing minimal clinically important difference in feelings of stress as assessed by Perceived Stress Scale (PSS-10) (score 10-50; where lower scores correspond to less stress)
Minimal clinically important difference (MCID) in sexual desire
Minimal clinically important difference (MCID) in sexual desire: Likelihood of experiencing minimal clinically important difference in sexual desire score as assessed by single self report item Sexual Desire (scale 1-7; where higher scores correspond to greater sexual desire)
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