Radicle Spark for Men 24: A Study of Health and Wellness Products on Sexual Health and Related Health Outcomes

NCT06590337 | Completed

• 1 other identifier: RADX-P-2413
• Study Type: interventional
• Target: 1,202
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on sexual health and related health outcomes

Conditions

Sexual Satisfaction; Sexual Function

Outcome Measures

Primary Outcomes (1)

• Change in sexual health

  Difference between rates of change over time in sexual health score as assessed by Patient Reported Outcome Measurement System (PROMIS) Brief Profile Sexual Function and Satisfaction Survey \[male version consists of 4 health domains assessed only among participants with sexual activity in the 30 days prior: erectile function (score range = 2-10; higher scores indicate better erectile function), orgasm ability (score range = 1-5; higher scores indicate more ability), orgasm pleasure (score range = 1-5; higher scores indicate more pleasure), satisfaction with sex life (score range = 2-10; higher scores indicate more satisfaction)\]

  6 weeks

Secondary Outcomes (7)

• Change in feelings of stress

  6 weeks

• Change in fatigue

  6 weeks

• Change in mood (emotional distress-depression)

  6 weeks

• Minimal clinical importance difference (MCID) in sexual health

  6 weeks

• Minimal clinical importance difference (MCID) in feelings of stress

  6 weeks

Other Outcomes (22)

• Change in saliva concentration of at-home (direct-to-consumer) specimen assay (1)

  6 weeks

• Change in saliva concentration of at-home (direct-to-consumer) specimen assay (2)

  6 weeks

• Change in saliva concentration of at-home (direct-to-consumer) specimen assay (3)

  6 weeks

Study Arms (4)

Placebo Control 1

PLACEBO COMPARATOR

Spark Product Form 1 - control

Dietary Supplement: Spark Placebo Control Form 1

Active Product 1.1

EXPERIMENTAL

Spark Product Form 1 - active product 1

Dietary Supplement: Spark Active Study Product 1.1 Usage

Placebo Control 2

PLACEBO COMPARATOR

Spark Product Form 2 - control

Dietary Supplement: Spark Placebo Control Form 2

Active Product 2.1

EXPERIMENTAL

Spark Product Form 2 - active product 1

Dietary Supplement: Spark Active Study Product 2.1 Usage

Interventions

Spark Placebo Control Form 1 DIETARY_SUPPLEMENT

Participants will use their Radicle Spark Placebo Control Form 1 as directed for a period of 6 weeks.

Placebo Control 1

Spark Active Study Product 1.1 Usage DIETARY_SUPPLEMENT

Participants will use their Radicle Spark Active Study Product 1.1 as directed for a period of 6 weeks.

Active Product 1.1

Spark Placebo Control Form 2 DIETARY_SUPPLEMENT

Participants will use their Radicle Spark Placebo Control Form 2 as directed for a period of 6 weeks.

Placebo Control 2

Spark Active Study Product 2.1 Usage DIETARY_SUPPLEMENT

Participants will use their Radicle Spark Active Study Product 2.1 as directed for a period of 6 weeks.

Active Product 2.1

Eligibility Criteria

• Age: 21 Years - 105 Years
• Gender Eligibility Details: Assigned sex at birth is male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radicle Science: lead

Study Sites (1)

Radicle Science, Inc

Del Mar, California, 92014, United States

Location

Related Links

• Radicle Science, Inc

MeSH Terms

Conditions

Orgasm

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Study Officials

• Emily K. Pauli, PharmD

  Radicle Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The investigator is blinded to the participants' study product assignment. Participants are blinded to the study product they are assigned.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be stratified based on their age and health outcome score during enrollment, then randomized to one of the study arms. Each participant will have an equal chance of being assigned to any study arm.

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: September 19, 2024
• Study Start: October 7, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: November 28, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)