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.
This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States. Eligible participants are (1) female, (2) experience issues with sexual desire, (3) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, and (2) express acceptance in taking a product and not knowing its formulation until the end of the study. 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 for 13 weeks. Participant reports of health indicators will be collected at enrollment and throughout the active period of study product usage. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
1,100
Participants will use their Active Sexual Health Product 1 as directed for a period of 12 weeks
Participants will use their Active Sexual Health Product 2 as directed for a period of 12 weeks
Participants will use their Active Sexual Health Product 3 as directed for a period of 12 weeks
Radicle Science Inc.
Del Mar, California, United States
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.
Time frame: 13 weeks
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.
Time frame: 13 weeks
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.
Time frame: 13 weeks
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)
Time frame: 13 weeks
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)
Time frame: 13 weeks
Change in mood (emotional distress-depression)
Change in mood (emotional distress-depression): Difference in rates of change over time in emotional distress score as assessed by PROMIS Emotional Distress- Depression 8A (score 8-40; with higher scores corresponding to greater levels of emotional distress)
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Participants will use their Placebo Sexual Health Control Product as directed for a period of 12 weeks
Time frame: 13 weeks