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

NCT06749288 | Completed

• 1 other identifier: RADX-P-2414
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (13)

• Change in feelings of anxiety

  Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety)

  6 weeks

• Change in feelings of anxiety

  Mean difference in anxiety score as assessed by PROMIS Anxiety 8A (scale 8-40; with higher scores corresponding to more severe anxiety)

  6 weeks

• Change in feelings of depression

  Mean difference in depression score as assessed by PROMIS Depression 4A (scale 4-20; with higher scores corresponding to more severe depression)

  6 weeks

• Change in cognitive function

  Mean difference in cognitive function score as assessed by PROMIS Cognitive Function 4A (scale 4-20; with lower scores corresponding to better cognitive function)

  6 weeks

• Change in cognitive function

  Mean difference in cognitive function score as assessed by PROMIS Cognitive Function 8A (scale 8-40; with lower scores corresponding to better cognitive function)

  6 weeks

• Change in sleep disturbance

  Mean difference in sleep disturbance score as assessed by PROMIS Sleep Disturbance 4A (scale 4-20; with higher scores corresponding to more severe sleep disturbance)

  6 weeks

• Change in sleep disturbance

  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)

  6 weeks

• Change in fatigue

  Mean difference in fatigue score as assessed by PROMIS Fatigue 4A (scale 4-20; with higher scores corresponding to more severe fatigue)

  6 weeks

• Change in feelings of depression

  Mean difference in depression score as assessed by PROMIS Depression 8A (scale 8-40; with higher scores corresponding to more severe depression)

  6 weeks

• Change in fatigue

  Mean difference in fatigue score as assessed by PROMIS Fatigue 8A (scale 8-40; with higher scores corresponding to more severe fatigue)

  6 weeks

• Change in Pain Interference

  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)

  6 weeks

• Change in pain intensity

  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)

  6 weeks

• Change in interest in sexual activity

  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)

  6 weeks

Secondary Outcomes (14)

• Change in other menopausal health issues

  6 weeks

• Minimal clinically important difference (MCID) in feelings of anxiety

  6 weeks

• Minimal clinically important difference (MCID) in feelings of anxiety

  6 weeks

• Minimal clinically important difference (MCID) in feelings of depression

  6 weeks

• Minimal clinically important difference (MCID) in feelings of depression

  6 weeks

Study Arms (2)

Placebo control 4.1.0

PLACEBO COMPARATOR

Revive product form 4.1 - control

Dietary Supplement: Radicle Revive Placebo Control Form 4.1

Active product 4.1.1

EXPERIMENTAL

Revive product form 4.1 - active product 1

Dietary Supplement: Radicle Revive Active Study Product 4.1 Usage

Interventions

Radicle Revive Placebo Control Form 4.1 DIETARY_SUPPLEMENT

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

Placebo control 4.1.0

Radicle Revive Active Study Product 4.1 Usage DIETARY_SUPPLEMENT

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

Active product 4.1.1

Eligibility Criteria

• Age: 21 Years - 105 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radicle Science: lead

Study Sites (1)

Radicle Science, Inc

Del Mar, California, 92014, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Parasomnias; Anxiety Disorders; Depression; Fatigue

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be stratified then randomized to one of the study arms. Each participant will have an equal chance of being assigned to each study arm.

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 27, 2024
• Study Start: January 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)