NCT06590337

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,202 (actual)
• Sponsor: Radicle Science · Industry
• Sex: Male
• Age: 21 Years – 105 Years
• Healthy volunteers: Accepted

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, 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.

Conditions

• Sexual Satisfaction
• Sexual Function

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Spark Placebo Control Form 1	Participants will use their Radicle Spark Placebo Control Form 1 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENT	Spark Active Study Product 1.1 Usage	Participants will use their Radicle Spark Active Study Product 1.1 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENT	Spark Placebo Control Form 2	Participants will use their Radicle Spark Placebo Control Form 2 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENT	Spark Active Study Product 2.1 Usage	Participants will use their Radicle Spark Active Study Product 2.1 as directed for a period of 6 weeks.

Timeline

• Start date: 2024-10-07
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2024-09-19
• Last updated: 2025-11-28

Locations

1 site across 1 country: United States