Radicle Revive 24: A Study of Health and Wellness Products on Hormonal Health and Associated Health Outcomes in Women With Peri-Menopausal Health Issues

NCT07117994 | Completed

• 1 other identifier: RADX_P_2414_VPH
• 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 Peri-Menopausal Health Issues

Conditions

Menopause; Fatigue; Sleep; Stress

Outcome Measures

Primary Outcomes (1)

• Change in Perceived Stress

  Change in perceived stress: Difference between rates of change over time in Perceived Stress score as assessed by NIH Toolbox Perceived Stress Survey (scale 10-50; where the higher scores correspond to worse perceived stress)

  6 weeks

Secondary Outcomes (7)

• Change in General Menopausal Health

  6 weeks

• Change in Sleep Disturbance

  6 weeks

• Change in Fatigue

  6 weeks

• Minimal clinically important difference (MCID) in perceived stress

  7 weeks

• Minimal clinically important difference (MCID) in menopausal health issues

  7 weeks

Study Arms (2)

Placebo Control 1

PLACEBO COMPARATOR

Radicle Revive Placebo Control Form 1

Dietary Supplement: Radicle Revive Placebo Control Form 1

Active Product 1

EXPERIMENTAL

Radicle Revive Active Study Product 1

Dietary Supplement: Radicle Revive Active Study Product 1

Interventions

Radicle Revive Placebo Control Form 1 DIETARY_SUPPLEMENT

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

Placebo Control 1

Radicle Revive Active Study Product 1 DIETARY_SUPPLEMENT

Participants will use their Radicle Revive Active Study Product 1 as directed for a period of 6 weeks.

Active 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:

• 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 is female
• Resides in the United States
• Identifies menstrual status as perimenopausal
• Has the opportunity for at least 30% improvement in their primary health outcome
• Indicates having peri-menopausal issues for 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 will be excluded from participation:
• Reports being 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
• 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, 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 to participants
• Reports an allergy to and/or disinterest in any of the possible study product ingredients
• Lack of reliable daily access to the internet

Sponsors & Collaborators

• Radicle Science: lead

Study Sites (1)

Radicle Science, Inc

Del Mar, California, 92014-2605, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Susan Hewlings

  Radicle Science Inc.

  PRINCIPAL INVESTIGATOR

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: August 5, 2025
• First Posted: August 12, 2025
• Study Start: August 5, 2025
• Primary Completion: November 12, 2025
• Study Completion: November 12, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)