Radicle Spark for Men 24: A Study of Health and Wellness Products on Sexual Health and Related Health Outcomes
- Conditions
- Sexual SatisfactionSexual Function
- Interventions
- Dietary Supplement: Spark Placebo Control Form 1Dietary Supplement: Spark Active Study Product 1.1 UsageDietary Supplement: Spark Placebo Control Form 2Dietary Supplement: Spark Active Study Product 2.1 Usage
- Registration Number
- NCT06590337
- Lead Sponsor
- Radicle Science
- Brief Summary
A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on sexual health and related health outcomes
- Detailed Description
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, 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 600
- 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 male
- Resides in the United States
- Endorses as improved libido (sex drive), sexual satisfaction and/or function as a primary desire
- Has the opportunity for at least 30% improvement in their primary health outcome
- Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study
- 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: NYHA (New York Heart Health) Class Ill 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. 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, MAOls (monoamine oxidase inhibitors), 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
- Lack of reliable daily access to the internet
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Control 1 Spark Placebo Control Form 1 Spark Product Form 1 - control Active Product 1.1 Spark Active Study Product 1.1 Usage Spark Product Form 1 - active product 1 Placebo Control 2 Spark Placebo Control Form 2 Spark Product Form 2 - control Active Product 2.1 Spark Active Study Product 2.1 Usage Spark Product Form 2 - active product 1
- Primary Outcome Measures
Name Time Method Change in sexual health 6 weeks Mean difference in sexual health score as assessed by Patient Reported Outcome Measurement System (PROMIS) Full Profile Sexual Function and Satisfaction Survey (Male) (scale 35 - 56; where lower scores correspond to lower sexual function and satisfaction)
- Secondary Outcome Measures
Name Time Method Change in feelings of stress 6 weeks 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)
Change in fatigue 6 weeks 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)
Change in mood (emotional distress-depression) 6 weeks 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)
Minimal clinical importance difference (MCID) in sexual health 6 weeks 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 (Male) (scale 35 - 56; where lower scores correspond to lower sexual function and satisfaction)
Minimal clinical importance difference (MCID) in feelings of stress 6 weeks 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)
Minimal clinical importance difference (MCID) in fatigue 6 weeks 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)
Minimal clinical importance difference (MCID) in mood (emotional distress-depression) 6 weeks 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)
Trial Locations
- Locations (1)
Radicle Science, Inc
🇺🇸Del Mar, California, United States