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

Last updated: November 12, 2024
Sponsor: Radicle Science
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Spark Active Study Product 1.1 Usage

Spark Placebo Control Form 2

Spark Placebo Control Form 1

Clinical Study ID

NCT06590337
RADX-P-2413
  • Ages 21-105
  • Male
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults, at least 21 years of age at the time of electronic consent, inclusive of allethnicities, 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 aprimary 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

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 perday)

  • Unable to read and understand English

  • Reports a current and/or recent (up to 3 months ago) major illness and/or surgerythat poses a known, significant safety risk

  • Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents aknown contraindication and/or a significant safety risk with any of the studyproduct ingredients: NYHA (New York Heart Health) Class Ill or IV congestive heartfailure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liverdisease, stage 3b or 4 chronic kidney disease, or kidney failure

  • Reports taking medications that have a well-established moderate or severeinteraction, posing a substantial safety risk with any of the study productingredients. Anticoagulants, antihypertensives, anxiolytics, antidepressants,chemotherapy. immunotherapy, sedative hypnotics, seizure medications, medicationsthat warn against grapefruit consumption, corticosteroids at doses greater than 5 mgper day, diabetic medications, oral anti-infectives (antibiotics, antifungals,antivirals) to treat an acute infection, antipsychotics, MAOls (monoamine oxidaseinhibitors), or thyroid products

  • Reports current use of the primary ingredient(s) and/or similar product(s) to theactive study product(s) that may limit the effects of the study products

  • Lack of reliable daily access to the internet

Study Design

Total Participants: 600
Treatment Group(s): 4
Primary Treatment: Spark Active Study Product 1.1 Usage
Phase:
Study Start date:
August 22, 2024
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Radicle Science, Inc

    Del Mar, California 92014
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.