Status:
COMPLETED
Radicle Spark for Men 24: A Study of Health and Wellness Products on Sexual Health and Related Health Outcomes
Lead Sponsor:
Radicle Science
Conditions:
Sexual Satisfaction
Sexual Function
Eligibility:
MALE
21-105 years
Phase:
NA
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, sex...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2025
Estimated Enrollment :
1202 Patients enrolled
Trial Details
Trial ID
NCT06590337
Start Date
October 7 2024
End Date
January 1 2025
Last Update
November 28 2025
Active Locations (1)
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1
Radicle Science, Inc
Del Mar, California, United States, 92014