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 will (1) endorse a desire for improved libido (sex drive), sexual satisfaction and/or function, (2) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study. 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 for 7 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
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
600
Participants will use their Radicle Spark Placebo Product 5.1 as directed for a period of 6 weeks.
Participants will use their Radicle Spark Active Study Product 5.1 as directed for a period of 6 weeks.
Radicle Science, Inc
Del Mar, California, United States
Change in sexual health
Mean difference in sexual health score as assessed by Patient Reported Outcome Measurement System (PROMIS) Full Profile Sexual Function and Satisfaction Survey (Female) (where lower scores correspond to lower sexual function and satisfaction)
Time frame: 6 weeks
Change in feelings of stress
Mean difference in feelings of stress score as assessed by Perceived Stress Scale 4 (PSS-4) (scale 0-16; where lower scores correspond to less stress)
Time frame: 6 weeks
Change in fatigue
Mean difference in fatigue as assessed by Patient Reported Outcome Measurement System (PROMIS) Fatigue 4A (scale 4-20; where higher scores correspond to more severe fatigue)
Time frame: 6 weeks
Change in mood (emotional distress-depression)
Mean difference in mood score as assessed by PROMIS Emotional Distress- Depression 4A (scale 4-20; where higher scores correspond to more severe emotional distress-depression)
Time frame: 6 weeks
Minimal clinical importance difference (MCID) in sexual health
Likelihood of achieving a MCID in sexual health score as assessed by Patient Reported Outcome Measurement System (PROMIS) Full Profile Sexual Function and Satisfaction Survey (Female) (where lower scores correspond to lower sexual function and satisfaction)
Time frame: 6 weeks
Minimal clinical importance difference (MCID) in feelings of stress
Likelihood of achieving a MCID in feelings of stress score as assessed by Perceived Stress Scale 4 (PSS-4) (scale 0-16; where lower scores correspond to less stress)
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Time frame: 6 weeks
Minimal clinical importance difference (MCID) in fatigue
Likelihood of achieving a MCID in feelings of fatigue score as assessed by Patient Reported Outcome Measurement System (PROMIS) Fatigue 4A (scale 4-20; where higher scores correspond to more severe fatigue)
Time frame: 6 weeks
Minimal clinical importance difference (MCID) in mood (emotional distress-depression)
Likelihood of achieving a MCID in mood score as assessed by PROMIS Emotional Distress- Depression 4A (scale 4-20; where higher scores correspond to more severe emotional distress-depression)
Time frame: 6 weeks