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

NCT07572578 | Not Yet Recruiting

• 1 other identifier: RADX_P_2608_DIF
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fatigue

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in cognitive function

  7 weeks

• Change in feelings of anxiety

  7 weeks

• Change in menopausal quality of life

  7 weeks

Other Outcomes (4)

• Minimal clinically important difference (MCID) in fatigue

  7 weeks

• Minimal clinically important difference (MCID) in cognitive function

  7 weeks

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

  7 weeks

Study Arms (2)

Placebo Control

PLACEBO COMPARATOR

Fatigue Product Placebo Control

Dietary Supplement: Fatigue Product Placebo Control

Active Product 1

EXPERIMENTAL

Fatigue Active Product 1

Dietary Supplement: Fatigue Active Product 1

Interventions

Fatigue Product Placebo Control DIETARY_SUPPLEMENT

Participants will use their Fatigue Product Placebo Control as directed for a period of 6 weeks.

Placebo Control

Fatigue Active Product 1 DIETARY_SUPPLEMENT

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

Active Product 1

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

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

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Susan Hewlings

  Radicle Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Manager

CONTACT

858-779-0086; studymgmt@radiclescience.com

Susan Hewlings

CONTACT

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 their age 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: May 1, 2026
• First Posted: May 7, 2026
• Study Start (Estimated): May 11, 2026
• Primary Completion (Estimated): May 11, 2027
• Study Completion (Estimated): May 11, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)