Status:
ACTIVE_NOT_RECRUITING
Radicle Menstrual Wellness™ CSP: A Trial Evaluating Plant-Based Health and Wellness Products on Menstrual Wellness in Premenopausal Women
Lead Sponsor:
Radicle Science
Conditions:
Menstrual Wellness
Eligibility:
FEMALE
21+ years
Phase:
NA
Brief Summary
A randomized, double-blind, placebo-controlled, trial evaluating plant-based health and wellness products on menstrual wellness in premenopausal women
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) are premenopausal, (3) have th...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 19 2026
Estimated Enrollment :
850 Patients enrolled
Trial Details
Trial ID
NCT07138339
Start Date
August 19 2025
End Date
August 19 2026
Last Update
October 2 2025
Active Locations (1)
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1
Radicle Science Inc.
Del Mar, California, United States, 92014