Impact of health and wellness products on men's sexual health
Radicle Spark for Men™ 24: 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 study is testing whether health and wellness products can improve sexual satisfaction and function in adult men.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 21 Years to 105 Years |
| Sex | Male |
| Sponsor | Radicle Science Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Del Mar, California) |
| Trial ID | NCT06590337 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, placebo-controlled study evaluates the effects of health and wellness products on sexual satisfaction and function among adult men in the United States. Participants will report their health indicators electronically over a 7-week period, with assessments conducted at baseline, during the study, and at the end. The study aims to determine if these products can lead to a meaningful improvement in sexual health outcomes. Participants will not know whether they are receiving the active product or a placebo until the conclusion of the study.
Who should consider this trial
Good fit: Ideal candidates are adult men aged 21 and older who desire improved libido, sexual satisfaction, or function.
Not a fit: Patients with known cardiac dysfunction, liver or kidney disease, or those who are heavy drinkers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance sexual health and satisfaction for men seeking improvement in these areas.
How similar studies have performed: While this approach is not widely tested, similar studies have shown promise in improving sexual health outcomes with wellness products.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Del Mar, California
- Radicle Science, Inc — Del Mar, California, United States (Recruiting)
Study contacts
- Principal investigator: Emily K. Pauli, PharmD — Radicle Science
- Study coordinator: Study Manager
- Email: studymgmt@radiclescience.com
- Phone: 760-281-3898
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.