Menstrual Wellness Product for Menstrual Cramps

Overseen By Susan Hewlings

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Radicle Science

Must not be taking: Anticoagulants, Antidepressants, Antipsychotics, others

Disqualifiers: Pregnancy, Cardiac dysfunction, Liver disease, others

Compensation: Varies

Number of Visits: Unknown

Duration: 13 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how a plant-based product, Menstrual Wellness Product 1, might alleviate menstrual cramps in premenopausal women. Participants will receive either the actual product or a placebo (a dummy treatment) to compare results. Those assigned female at birth, residing in the U.S., and experiencing regular periods with cramps may find this trial suitable. Participants must be willing to remain unaware of whether they are receiving the real product or the placebo until the study concludes. As an unphased trial, this study provides a unique opportunity to contribute to understanding potential new treatments for menstrual cramps.

Do I need to stop taking my current medications for the trial?

You may need to stop taking certain medications if they interact with the study product, such as blood thinners, blood pressure meds, or antidepressants. The trial doesn't specify a washout period, but it's important to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that participants have used the Menstrual Wellness Product 1 without major safety issues. Previous studies and reports indicate that similar products are generally well-tolerated. For instance, researchers found a non-drug patch for menstrual pain relief to be easy to use and safe. While this isn't the exact product being tested, it provides an idea of the type of product.

It's important to know that this trial isn't classified under a specific phase, often indicating limited safety information. However, testing in a controlled setting suggests some confidence in its safety. Always consult healthcare professionals if considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about the Menstrual Wellness Product 1 because it offers a potentially new way to relieve menstrual cramps. Unlike traditional treatments like NSAIDs or hormonal birth control, which target inflammation or hormone regulation, this product might use a unique blend of natural ingredients designed to provide comfort with fewer side effects. This approach could offer a more holistic and user-friendly option for individuals seeking alternative solutions for menstrual pain. The promise of a gentler, possibly more effective treatment is what makes it stand out in the field of menstrual wellness.

What evidence suggests that this trial's treatments could be effective for menstrual cramps?

Research has shown that palmitoylethanolamide (PEA), a key ingredient in Menstrual Wellness Product 1, can significantly reduce menstrual pain. One study found that women experienced a 25% decrease in pain just two and a half hours after using a product containing PEA. Participants in this trial may receive Menstrual Wellness Product 1, which could quickly alleviate period discomfort. While methods like exercise, acupressure, and heat can also provide relief, PEA offers a promising new option for those seeking to ease menstrual cramps. ^{1 6 7 8 9}

Who Is on the Research Team?

Susan Hewlings

Principal Investigator

Radicle Science

Are You a Good Fit for This Trial?

This trial is for premenopausal women experiencing menstrual cramps. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not be taking conflicting medications.

Inclusion Criteria

I am premenopausal.

Resides in the United States

Reports an average menstrual cycle length of 3 - 6 weeks

Exclusion Criteria

Unable to provide a valid US shipping address and mobile phone number

Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)

I've had a major illness or surgery in the last 3 months that could affect my safety in the trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive plant-based health and wellness products or placebo for menstrual wellness

13 weeks

All assessments are electronic; no in-person visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Menstrual Wellness Product 1
• Menstrual Wellness Product Placebo Control

Trial Overview The study is testing the effects of a plant-based Menstrual Wellness Product against a placebo (a harmless pill with no active ingredients). It's randomized and double-blind, meaning neither the researchers nor participants know who gets the real product or placebo.

How Is the Trial Designed?

Group I: Active Product 1 Experimental Treatment 1 Intervention

Menstrual Wellness Product 1

Group II: Placebo Control Placebo Group 1 Intervention

Menstrual Wellness Product Control

Who Is Running the Clinical Trial?

Radicle Science

Lead Sponsor

Trials

24

Recruited

46,200+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07138339

Radicle Menstrual Wellness™ CSP: A Trial Evaluating ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6337810/

The effectiveness of self-care and lifestyle interventions in ... Exercise showed large effects, while acupressure and heat showed moderate effects in reducing menstrual pain compared to no treatment.

3. nutraceuticalbusinessreview.com nutraceuticalbusinessreview.com/gencor-pea-ingredient-eases-menstrual-discomfort-study

PEA ingredient eases menstrual discomfort in new clinical ... Gencor's palmitoylethanolamide nutraceutical Levagen+ reduced pain scores by 25% in women with period pains two and a half hours after use.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0965229925001074

Effectiveness and safety of light therapy for treating primary ... The primary outcome was the change in pain severity, measured using validated pain scales such as the Visual Analog Scale (VAS) or Numeric Rating Scale (NRS).

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9905939/

Smartphone apps for menstrual pain and symptom ... 119 apps targeting menstrual experiences were retained. Pain and menstrual symptoms tracking were available in 64 % of apps.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9876534/

Menstrual products as a source of environmental chemical ... Nearly two dozen studies have been conducted measuring environmental contaminants in menstrual products; all have detected environmental chemicals.

7. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=9922379&pc=IMD

MAUDE Adverse Event Report: PFIZER CONSUMER ... She stated she had been using the product for ivs not for menstrual pain.She said the product helped with the cramps from the ivs.It helped with any other ...

8. ophrp.org ophrp.org/journal/view.php?doi=10.24171/j.phrp.2021.12.1.04

Use of Menstrual Sanitary Products in Women ... The most important criteria when choosing a menstrual hygiene product was comfort for disposable menstrual pads (31.3%) and tampons (41.5%), ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7233733/

Clinical monitoring of safety and functionality of a non- ... FIT® Lady patch is an easy-to-use class I medical device, developed to relieve pain associate to menstrual period, without pharmacological substances.