Radicle Women's HealthTM: A Study Assessing the Impact of Health and Wellness Products on Fatigue and Related Health Outcomes Among Women Experiencing Menopausal Symptoms

Radicle Women's HealthTM: A Randomized, Double-Blind, Placebo- Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Fatigue and Related Health Outcomes Among Women Experiencing Menopausal Symptoms

Radicle Women's HealthTM: A randomized, double-blind, placebo- controlled direct-to-consumer study assessing the impact of health and wellness products on fatigue and related health outcomes among women experiencing menopausal symptoms.

Study Overview

• Status: Not yet recruiting
• Conditions: Fatigue
• Intervention / Treatment: Dietary supplement: Fatigue Product Placebo Control; Dietary supplement: Fatigue Active Product 1

Detailed Description

This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States. Eligible participants (1) are female, (2) aged 35-60, (3) currently experience menopausal symptoms, (4) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, and (5) express acceptance in taking a product and not knowing its formulation 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 those who report they are pregnant, trying to become 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 enrollment and throughout the active period of study product usage. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.

• Study Type: Interventional
• Enrollment (Estimated): 550
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Study Manager; Phone Number: 858-779-0086; Email: studymgmt@radiclescience.com
• Study Contact Backup: Name: Susan Hewlings; Email: susan.hewlings@radiclescience.com

Study Locations

• United States
  • California
    • Del Mar, California, United States, 92014
      • Radicle Science Inc.
      • Contact: Study Manager; Phone Number: 760-281-3898; Email: studymgmt@radiclescience.com
      • Contact: Megan Mosely1; Email: megan@radiclescience.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

3.1 Inclusion

Participants must meet all the following criteria:

• Adults, 35-60 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities

  • Assigned sex at birth is female
• Experience at least two menopausal symptoms
• Resides in the United States
• Has the opportunity for at least 30% improvement in their primary health outcome
• Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study

3.2 Exclusion

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
• Reports surgical menopause/bilateral oophorectomy
• Reports taking HRT or prescription menopausal products

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Control; Fatigue Product Placebo Control	Dietary supplement: Fatigue Product Placebo Control; Participants will use their Fatigue Product Placebo Control as directed for a period of 6 weeks.
Experimental: Active Product 1; Fatigue Active Product 1	Dietary supplement: Fatigue Active Product 1; Participants will use their Fatigue Active Product 1 as directed for a period of 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chang in fatigue	Change in fatigue: Difference in rates of change over time in fatigue score as assessed by Patient Reported Outcome Measurement System (PROMIS) Fatigue 8A (scale 8-40; where higher scores correspond to more severe fatigue)	7 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	7 weeks
Change in feelings of anxiety	Change in feelings of anxiety: Difference between rates of change over time in feelings of anxiety score as assessed by PROMIS Anxiety 8A (scale 8-40; with higher scores corresponding to more severe anxiety)	7 weeks
Change in menopausal quality of life	Change in menopausal quality of life: Difference between rates of change over time in menopausal quality of life score as assessed by Menopause-specific Quality of Life Questionnaire (scale 1-8; where the higher scores correspond to worse menopausal quality of life)	7 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minimal clinically important difference (MCID) in cognitive function	Minimal clinically important difference (MCID) in cognitive function: Likelihood of experiencing minimal clinically important difference in cognitive function score as assessed by PROMIS Cognitive Function 8A (scale 8-40; where lower scores correspond to worse cognitive function)	7 weeks
Minimal clinically important difference (MCID) in fatigue	Minimal clinically important difference (MCID) in fatigue: Likelihood of experiencing minimal clinically important difference in fatigue score as assessed by PROMIS Fatigue 8A (scale 8-40; where higher scores correspond to more severe fatigue)	7 weeks
Minimal clinically important difference (MCID) in feelings of anxiety	Minimal clinically important difference (MCID) in feelings of anxiety: Likelihood of experiencing minimal clinically important difference in feelings of anxiety score as assessed by PROMIS Anxiety 8A (scale 8-40; with higher scores corresponding to more severe anxiety)	7 weeks
Minimal clinically important difference (MCID) in menopausal quality of life	Minimal clinically important difference (MCID) in menopausal quality of life: Likelihood of experiencing minimal clinically important difference in menopausal quality of life score as assessed by Menopause-specific Quality of Life Questionnaire (scale 1-8; where the higher scores correspond to worse menopausal quality of life)	7 weeks

Collaborators and Investigators

• Sponsor: Radicle Science
• Investigators: Principal Investigator: Susan Hewlings, Radicle Science

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): May 11, 2026
• Primary Completion (Estimated): May 11, 2027
• Study Completion (Estimated): May 11, 2027

Study Registration Dates

• First Submitted: May 1, 2026
• First Submitted That Met QC Criteria: May 1, 2026
• First Posted (Actual): May 7, 2026

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Fatigue
• Other Study ID Numbers: RADX_P_2608_DIF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will not be shared with researchers outside of Radicle Collaborators on this study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No