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

Radicle Science1,202 enrolled

Overview

A randomized, double-blind, placebo-controlled 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, 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

1,202

Conditions

Sexual Satisfaction Sexual Function

Interventions

Spark Placebo Control Form 1DIETARY_SUPPLEMENT

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

Spark Active Study Product 1.1 UsageDIETARY_SUPPLEMENT

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

Spark Placebo Control Form 2DIETARY_SUPPLEMENT

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

Eligibility

Sex: MALEMin age: 21 YearsMax age: 105 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Radicle Science, Inc

Del Mar, California, United States

Outcomes

Primary Outcomes

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 \[male version consists of 4 health domains assessed only among participants with sexual activity in the 30 days prior: erectile function (score range = 2-10; higher scores indicate better erectile function), orgasm ability (score range = 1-5; higher scores indicate more ability), orgasm pleasure (score range = 1-5; higher scores indicate more pleasure), satisfaction with sex life (score range = 2-10; higher scores indicate more satisfaction)\]

Time frame: 6 weeks

Secondary Outcomes

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) Brief Profile Sexual Function and Satisfaction Survey \[male version consists of 4 health domains assessed only among participants with sexual activity in the 30 days prior: erectile function (score range = 2-10; higher scores indicate better erectile function), orgasm ability (score range = 1-5; higher scores indicate more ability), orgasm pleasure (score range = 1-5; higher scores indicate more pleasure), satisfaction with sex life (score range = 2-10; higher scores indicate more satisfaction)\]

Data from ClinicalTrials.gov

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