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

Not Applicable

Recruiting

• Conditions: Menopause; Sleep Disturbance; Anxiety; Depression; Cognitive Function; Fatigue; Libido

• Registration Number: NCT06749288
• Lead Sponsor: Radicle Science

Brief 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.

Study Timeline

• Study First Submitted: 2024-12-19
• Study First Submitted QC: 2024-12-19
• Study First Posted: 2024-12-27
• Status Verified: 2025-01
• Study Start: 2025-01-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-09
• Primary Completion: 2026-01-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

• Adults, 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, genders and/or gender identities
• Resides in the United States
• Endorses less pain as a primary desire
• Selects pain and/or looking to improve their pain as a reason for their interest in taking a health and wellness product
• 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

• reports being pregnant, trying to become pregnant, or breastfeeding
• Unable to provide a valid US shipping address and mobile phone number
• The calculated validated health survey (PRO) score during enrollment represents less than mild severity
• Reports a diagnosis of liver or kidney disease
• Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
• Unable to read and understand English
• Reports current enrollment in a clinical trial
• Lack of reliable daily access to the internet
• Reports current or recent (within 3 months) use of chemotherapy or immunotherapy
• Reports taking medications with a known moderate or severe interaction with any of the active ingredients studied, or a substantial safety risk: Anticoagulants, a medication that warns against grapefruit consumption, corticosteroids at doses greater than 5 mgs per day, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, or MAO

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in feelings of anxiety	6 weeks	Mean difference in anxiety score as assessed by PROMIS Anxiety 8A (scale 8-40; with higher scores corresponding to more severe anxiety)
Change in feelings of depression	6 weeks	Mean difference in depression score as assessed by PROMIS Depression 8A (scale 8-40; with higher scores corresponding to more severe depression)
Change in cognitive function	6 weeks	Mean difference in cognitive function score as assessed by PROMIS Cognitive Function 8A (scale 8-40; with lower scores corresponding to better cognitive function)
Change in sleep disturbance	6 weeks	Mean difference in sleep disturbance score as assessed by PROMIS Sleep Disturbance 8A (scale 8-40; with higher scores corresponding to more severe sleep disturbance)
Change in fatigue	6 weeks	Mean difference in fatigue score as assessed by PROMIS Fatigue 8A (scale 8-40; with higher scores corresponding to more severe fatigue)
Change in Pain Interference	6 weeks	Mean difference in pain interference score as assessed by PROMIS Pain Interference 6A (scale 6-30; with higher scores corresponding to more severe pain interference)
Change in pain intensity	6 weeks	Mean difference in pain intensity score as assessed by PROMIS Pain Intensity 3A (scale 3-15; with higher scores corresponding to more severe pain intensity)
Change in interest in sexual activity	6 weeks	Mean difference in interest in sexual activity score as assessed by PROMIS Sexual Function and Satisfaction v2.0 (scale 2-10; with lower scores corresponding to less interest in sexual activity)

Secondary Outcome Measures

Name	Time	Method
Change in other menopausal health issues	6 weeks	Other menopausal health issues assessed by Radicle General Menopausal Health Issues (Point range: 10 - 48; where higher is more severe menopausal health issues)
Minimal clinically important difference (MCID) in feelings of anxiety	6 weeks	Likelihood of achieving a MCID in anxiety, as measured by PROMIS Anxiety 8a (8-40; where lower scores indicate less anxiety).
Minimal clinically important difference (MCID) in feelings of depression	6 weeks	Likelihood of achieving a MCID in depression , as measured by PROMIS Depression 8a (8-40; where lower scores indicate less depression).
Minimal clinically important difference (MCID) in cognitive function	6 weeks	Likelihood of achieving a MCID in cognitive function , as measured by PROMIS cognitive function 8a (8-40; where lower scores indicate poorer cognitive function).
Minimal clinically important difference (MCID) in sleep disturbance	6 weeks	Likelihood of achieving a MCID in sleep disturbance , as measured by PROMIS Sleep Disturbance 8a (8-40; where lower scores indicate less sleep disturbance).
Minimal clinically important difference (MCID) in fatigue	6 weeks	Likelihood of achieving a MCID in fatigue, as measured by PROMIS Fatigue 8a (8-40; where lower scores indicate less fatigue).
Minimal clinically important difference (MCID) in pain interference	6 weeks	Likelihood of achieving a MCID in pain interference, as measured by PROMIS Pain interference (6-30; where lower scores indicate less pain interference).
Minimal clinically important difference (MCID) in pain intensity	6 weeks	Likelihood of achieving a MCID in pain intensity, as measured by PROMIS Pain intensity (3-15; where lower scores indicate less pain intensity).
Minimal clinically important difference (MCID) in interest in sexual function	6 weeks	Likelihood of achieving a MCID in interest in sexual activity, as measured by PROMIS Sexual Function and Satisfaction v2.0 (scale 2-10; with lower scores corresponding to less interest in sexual activity)

Trial Locations

Locations (1)

Radicle Science, Inc; 🇺🇸 Del Mar, California, United States