Radicle Revive™: A Study Assessing the Impact of Health and Wellness Products on Menopausal-Related Health Issues Associated Health Outcomes and Related Health Outcomes

NCT07548307 | Recruiting

• 1 other identifier: RADX_P_2605_RGW
• Study Type: interventional
• Target: 990
• Locations: 1 country
• Sites: 1

Brief Summary

Radicle Revive™: A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on menopausal-related health issues associated health outcomes.

Conditions

Cognitive Function

Outcome Measures

Primary Outcomes (1)

• Change in cognitive function

  Change in cognitive function: Difference in rates of change over time in cognitive function score as assessed by PROMIS Cognitive Function 8A (scale 8-40; where lower scores correspond to worse cognitive function)

  13 weeks

Secondary Outcomes (8)

• Change in cognitive abilities

  13 weeks

• Change in feelings of anxiety

  13 weeks

• Hot Flash Interference over 12 weeks

  From Baseline to week 12 of product consumption.

• Hot Flash Frequency

  From baseline to day 14 of product consumption.

• Hot Flash Interference over 14 days

  From Baseline to day 14 of product consumption.

Other Outcomes (3)

• Minimal clinically important difference (MCID) in cognitive function

  13 weeks

• Minimal clinically important difference (MCID) in cognitive abilities

  13 weeks

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

  13 weeks

Study Arms (2)

Placebo Control

PLACEBO COMPARATOR

Revive Product Placebo Control

Dietary Supplement: Revive Product Placebo Control

Active Revive Product 1

EXPERIMENTAL

Revive Active Product 1

Dietary Supplement: Revive Active Product 1

Interventions

Revive Product Placebo Control DIETARY_SUPPLEMENT

Participants will use their Control as directed for a period of 12 weeks.

Placebo Control

Revive Active Product 1 DIETARY_SUPPLEMENT

Participants will use their Active product as directed for a period of 12 weeks.

Active Revive Product 1

Eligibility Criteria

• Age: 40 Years - 105 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet all the following criteria:
• Adults, at least 40 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities
• Assigned sex at birth will determine sex-specific recruitment
• Resides in the United States
• Has the opportunity for at least 30% improvement in their primary health outcome
• Peri or Post Menopausal women who have been experiencing hot flashes for the past 3 months or longer
• 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:

• Individuals who report any of the following during screening may be excluded from participation:
• Report being pregnant, trying to become pregnant, or breastfeeding
• 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 per day)
• Unable to read and understand English at a 7th grade level
• Reports a current and/or recent (up to 3 months ago) major illness and/or surgery that poses a known, significant safety risk.
• Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known contraindication and/or a significant safety risk with any of the study product ingredients.
• NYHA Class III or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure
• Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients.
• Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs, or thyroid products
• Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s) that may limit the effects of the study products and/or pose a safety risk
• Lack of reliable daily access to the internet
• Currently taking a HRT medication
• Pre-Menopausal women

Sponsors & Collaborators

• Radicle Science: lead

Study Sites (1)

Radicle Science Inc.

Del Mar, California, 92014, United States

RECRUITING

Related Links

• Related Info

Study Officials

• Susan Hewlings

  Radicle Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Manager

CONTACT

858-779-0086; studymgmt@radiclescience.com

Susan Hewlings

CONTACT

760-281-3898; susan.hewlings@radiclescience.com

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 based on menstrual status, hot flash interference, and health outcome score during enrollment, then randomized to one of the study arms. Each participant will have an equal chance of being assigned to any study arm.

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 23, 2026
• Study Start: April 9, 2026
• Primary Completion (Estimated): April 7, 2027
• Study Completion (Estimated): April 7, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)