Menstrual WellnessNCT07138339
Radicle Menstrual Wellness™ CSP: A Trial Evaluating Plant-Based Health and Wellness Products on Menstrual Wellness in Premenopausal Women
A study testing Menstrual Wellness Product 1 in people with Menstrual Wellness, run by Radicle Science at 1 site in United States.
Trial summary
A randomized, double-blind, placebo-controlled, trial evaluating plant-based health and wellness products on menstrual wellness in premenopausal women Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Wellness
- What is being tested?
- Menstrual Wellness Product 1
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 850 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2025to 20 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radicle Menstrual Wellness™ CSP: A Randomized, Double-Blind, Placebo-Controlled, Trial Evaluating Plant-Based Health and Wellness Products on Menstrual Wellness in Premenopausal Women
A randomized, double-blind, placebo-controlled, trial evaluating plant-based health and wellness products on menstrual wellness in premenopausal women
Read the 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.
- Conditions
- Menstrual Wellness
- Being tested
- Menstrual Wellness Product Placebo Control, Menstrual Wellness Product 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menstrual Wellness Product Placebo ControlDietary supplement
Participants will use their Menstrual Wellness Product Placebo Control as directed for a period of 12 weeks
Menstrual Wellness Product 1Dietary supplement
Participants will use their Menstrual Wellness Product 1 as directed for a period of 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo Control | Placebo comparator | Menstrual Wellness Product Control Receives: Dietary Supplement: Menstrual Wellness Product Placebo Control |
| Active Product 1 | Experimental | Menstrual Wellness Product 1 Receives: Dietary Supplement: Menstrual Wellness Product 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 13 weeks
Secondary outcomes (3)
Change in Wellbeing
Difference between rates of change over time in Wellbeing as assessed by WHO-5 (scale 0-25; higher scores = better wellbeing)
Measured: 13 weeks
Change in Pain Interference
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)
Measured: 13 weeks
Change in Pain Intensity
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)
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start19 Aug 2025
- Primary completion20 Jan 2026
- Study completion20 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual WellnessStudies of the same condition, open and under way.
- More trials run by Radicle ScienceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 850 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radicle Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susan Hewlings, Principal investigator, Radicle Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07138339
- Sponsor's protocol ID
- RADX_C_2506_SP
- Status last verified
- Aug 2025
- First submitted
- 15 Aug 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared with researchers outside of Radicle Collaborators on this study.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radicle Menstrual Wellness™ CSP: A Randomized, Double-Blind, Placebo-Controlled, Trial Evaluating Plant-Based Health and Wellness Products on Menstrual Wellness in Premenopausal Women
- ClinicalTrials.gov ID
- NCT07138339
- Acronym / sponsor ID
- RADX_C_2506_SP
- Conditions
- Menstrual Wellness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 850 participants (actual)
- Lead sponsor
- Radicle ScienceIndustry (pharma, biotech, devices)
- Study start
- 19 Aug 2025 (actual)
- Primary completion
- 20 Jan 2026 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo Control | Placebo comparator | Dietary Supplement: Menstrual Wellness Product Placebo ControlMenstrual Wellness Product Control |
| Active Product 1 | Experimental | Dietary Supplement: Menstrual Wellness Product 1Menstrual Wellness Product 1 |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Menstrual Wellness Product Placebo ControlParticipants will use their Menstrual Wellness Product Placebo Control as directed for a period of 12 weeks | Dietary supplement | Placebo Control |
| Menstrual Wellness Product 1Participants will use their Menstrual Wellness Product 1 as directed for a period of 12 weeks | Dietary supplement | Active Product 1 |
Primary outcome
Change in Menstrual Distress
Time frame: 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)
3 secondary outcomes
Change in Wellbeing
Time frame: 13 weeks
Change in Pain Interference
Time frame: 13 weeks
Change in Pain Intensity
Time frame: 13 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data will not be shared with researchers outside of Radicle Collaborators on this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Hewlings principal investigator
Radicle Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Menstrual Wellness Product 1 in people with Menstrual Wellness, run by Radicle Science at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Menstrual Distress (time frame: 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.