Menstrual Wellness
Conditions
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 the opportunity for meaningful improvement (at least 30%) in their primary health outcome, and (4) express acceptance in taking study products and not knowing the formulation identities 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 women who 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 13 weeks. Participant reports of health indicators will be collected at baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.
Interventions
DIETARY_SUPPLEMENTMenstrual Wellness Product 1
Participants will use their Menstrual Wellness Product 1 as directed for a period of 12 weeks
DIETARY_SUPPLEMENTMenstrual Wellness Product Placebo Control
Participants will use their Menstrual Wellness Product Placebo Control as directed for a period of 12 weeks
Sponsors
Radicle Science
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received.
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Menstrual Distress | 13 weeks | Difference between rates of change over time in Menstrual Distress as assessed by MEDI-Q (scale 0-125; higher scores = worse menstrual distress) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Wellbeing | 13 weeks | Difference between rates of change over time in Wellbeing as assessed by WHO-5 (scale 0-25; higher scores = better wellbeing) |
| Change in Pain Interference | 13 weeks | Difference in rates of change over time in pain interference score as assessed by PROMIS Pain Interference 6A (scale 6-30; with higher scores corresponding to more severe pain interference) |
| Change in Pain Intensity | 13 weeks | Difference in rates of change over time in pain intensity score as assessed by PROMIS Pain Intensity 3A (scale 3-15; with higher scores corresponding to more severe pain intensity) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSusan Hewlings
Radicle Science
Outcome results
None listed