NCT06749288

Radicle Revive 24: A Study of Health and Wellness Products on Menopausal Health and Related Health Outcomes

Radicle Revive™ 24: A Randomized, Double-Blind, Placebo-Controlled, Direct-to-Consumer Trial Assessing the Impact of Health and Wellness Products on Hormonal Health and Associated Health Outcomes in Women With Menopausal Health Issues

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: Radicle Science · Industry
• Sex: Female
• Age: 21 Years – 105 Years
• Healthy volunteers: Accepted

Summary

A randomized, double-blind, placebo-controlled, direct-to-consumer trial assessing the impact of health and wellness products on hormonal health and associated health outcomes in women with menopausal health issues

Detailed description

This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States. Eligible participants (1) are females, (2) have menopausal health issues for 3 months or longer, (3) have the opportunity to improve by at least 30%, and (4) express acceptance in taking study products and not knowing the formulation identities 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 and women who are pregnant or breastfeeding 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

• Menopause
• Sleep Disturbance
• Anxiety
• Depression
• Cognitive Function
• Fatigue
• Libido

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Radicle Revive Placebo Control Form 4.1	Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENT	Radicle Revive Active Study Product 4.1 Usage	Participants will use their Radicle Revive Active Study Product 1.1 as directed for a period of 6 weeks.

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2024-12-27
• Last updated: 2025-07-04

Locations

1 site across 1 country: United States