Radicle Menstrual Wellness™ CSP: A Trial Evaluating Plant-Based Health and Wellness Products on Menstrual Wellness in Premenopausal Women

NCT07138339 | Completed

• 1 other identifier: RADX_C_2506_SP
• Study Type: interventional
• Target: 850
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, double-blind, placebo-controlled, trial evaluating plant-based health and wellness products on menstrual wellness in premenopausal women

Conditions

Menstrual Wellness

Outcome Measures

Primary Outcomes (1)

• Change in Menstrual Distress

  Difference between rates of change over time in Menstrual Distress as assessed by MEDI-Q (scale 0-125; higher scores = worse menstrual distress)

  13 weeks

Secondary Outcomes (3)

• Change in Wellbeing

  13 weeks

• Change in Pain Interference

  13 weeks

• Change in Pain Intensity

  13 weeks

Other Outcomes (4)

• Minimal clinical importance difference (MCID) in Menstrual Wellness

  13 weeks

• Minimal clinically important difference (MCID) in pain intensity

  13 weeks

• Minimal clinical importance difference (MCID) in Wellbeing

  13 weeks

Study Arms (2)

Placebo Control

PLACEBO COMPARATOR

Menstrual Wellness Product Control

Dietary Supplement: Menstrual Wellness Product Placebo Control

Active Product 1

EXPERIMENTAL

Menstrual Wellness Product 1

Dietary Supplement: Menstrual Wellness Product 1

Interventions

Menstrual Wellness Product 1 DIETARY_SUPPLEMENT

Participants will use their Menstrual Wellness Product 1 as directed for a period of 12 weeks

Active Product 1

Menstrual Wellness Product Placebo Control DIETARY_SUPPLEMENT

Participants will use their Menstrual Wellness Product Placebo Control as directed for a period of 12 weeks

Placebo Control

Eligibility Criteria

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

You may qualify if:

• Adults, at least 21 years old 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 premenopausal
• Reports an average menstrual cycle length of 3 - 6 weeks
• 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

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
• 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, United States

Location

Related Links

• Related Info

Study Officials

• Susan Hewlings

  Radicle Science

  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 based on their age, menstrual pain, 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 each study arm.

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: August 22, 2025
• Study Start: August 19, 2025
• Primary Completion: January 20, 2026
• Study Completion: January 20, 2026
• Last Updated: January 23, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)