- Clinical trials -

menstrual wellbeing

Capture a holistic view of how your product supports well-being during the menstrual cycle.

period pain

clinical trials for PMS support

Over 90% of females report experiencing a combination of symptoms before or during their period. 

Products capable of reducing or eliminating these symptoms deliver improved quality of life, enhanced productivity, and higher quality emotional health, resulting in a substantial market for natural supplements. With more and more consumers expecting scientific substantiation for marketing promises made, clinical trials on PMS products are now a must. 

Findings from a clinical trial unlock numerous new avenues for marketing, brand integrity, and even stability. These findings allow you to legally and ethically make marketing claims that your product improves menstrual health. They also supply the documentation required for FDA and FTC compliance. 

Ensuring that your product is clinically proven to reduce PMS symptoms, alleviate cramping or bloating, or enhance mood also improves consumer trust in your product's quality and capabilities, providing you a powerful marketing advantage. 

 

PMS Claim Substantiation

With high quality clinical trials developed specifically for your unique product, you can gain access to new market claims. Over 50% of consumers rely on product claims when making supplement decisions, but use of claims requires high quality scientific substantiation. A clinical trial can make it possible to include phrases such as: 

  • Balances mood during menstruation
  • For mild cramps associated with the menstrual cycle
  • For temporary premenstrual water weight gain 
  • Reduces bloating caused by PMS
  • Relieves minor pain associated with the menstrual cycle

For claim substantiation, product-specific clinical trials conducted on individuals which match your target market is the gold standard. Failing to properly or sufficiently substantiate a product claim can result in costly and embarrassing regulatory actions. Franklin Health Research specializes in clinical research for the natural products industry using methodology and measurements developed exclusively for this market. 

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of women regularly consume natural supplements

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of women experience symptoms associated with PMS

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of supplement consumers expect to see clinical trials on their products

outcome measures for female health

To substantiate a claim with a clinical trial, the overarching goal is straightforward: document efficacy. A typical trial on natural products involves measuring the effect of your product in a treatment group and comparing it to a placebo group. This is done using statistical tests which can establish whether or not the difference in brain health can be attributed to the treatment. The key to this process is outcome measurement. If the wrong tool is used to measure brain health, your entire trial is at risk of failure. 

Despite the clear importance of using the correct measurement tools, the overwhelming majority of measurement tools used in clinical research on brain health were actually developed to screen patients for signs of dementia or to identify patients with traumatic brain injuries. Yet, consumers of natural products have different goals: they are trying to improve memory, eliminate brain fog, or enhance mental acuity. Screening tools for dementia are incapable of capturing improvements to an already healthy brain. Using the wrong measurement strategy guarantees that your study will fail to capture the true power of your product. Franklin Health Research solves this common problem through the use of proprietary brain health measurement tools developed exclusively for the natural products industry. 

Capturing the adverse symptoms of the female menstrual cycle requires a comprehensive, holistic tool which is capable of capturing the wide range of symptoms females experience.

Despite the diversity of PMS of symptoms the overwhelming majority of tools available for PMS research focus heavily, if not exclusively, on how female menstrual symptoms affect productivity and relationships with others. These tools overemphasize on symptoms such as anger and irritability, neglecting the impact of menstrual symptoms such as digestive complaints, fatigue, and pain. 

 

pms cramp

 

Franklin Menstrual Well-Being Questionnaire (FMWB)

The Franklin Health Research team of measurement experts has developed and validated a comprehensive tool for quantifying PMS-related disturbance. This tool captures a holistic view of symptoms, delivering a comprehensive approach to identifying how your unique products improves female health during their period. This also protects your trial from false negatives and enhances the potential for documenting a wider range of health benefits. 

The comprehensive FMWB scale quantifies the extent to which your product improves symptoms during the premenstrual and menstrual period. It measures 7 domains including pain, emotional well-being, mental well-being, cognition, stress, digestive symptoms, and sleep quality. This comprehensive overview of symptoms allows our team to identify exactly how your product improves female health, delivering robust substantiation for your claims. 

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the clinical trial process

Your project will begin with a  30-60 minute virtual meeting, during which we will learn everything we need to know about your product's key benefits so that we can capture them in a trial. Does your product focus on water retention? Pain and cramping? Mood and stress? Your product formulation is unique and specific, and your clinical trial should reflect that.  

Next, our research team will develop a customized research proposal outlining just how we plan to capture your PMS product's greatest benefits. We'll address all of the details from dosing strategies to trial duration, target market, and more, all while keeping your project budget in mind. Your proposal is good for 60 days, allowing ample time for internal reviews, requested adjustments, and other details. Once we execute a trial agreement, the fun begins! 

working with franklin

Franklin Health Research is the only research firm in the supplement industry with deep roots in the natural products field. During our early days as an herbalism and aromatherapy college, we trained some of the nation's leading integrative health experts, and our team now focuses exclusively on high quality clinical research tailored to meet the unique needs of natural and botanically based products. 

This foundation is critical to success with nutraceutical clinical research; without methods, measurements, and protocols developed specifically for the natural products industry, clinical trial projects can quickly become laden with unnecessary expenses, needless overhead, and outdated strategies borrowed from the pharmaceutical industry. 

We build your trial around your specific product using strategies that protect your study from common sources of failure. i.e. Roughly 80% of nutraceutical trials fail to meet recruitment deadlines and the overwhelming majority fail to fully capture a nutraceutical's key benefits. Our innovative approaches based on our unique experience protects your study from common yet disastrous mistakes. 

 

Clinical trials for PMS

Ready to get started? Schedule your FREE 30-minute consultation with our research team to discuss your strategies and needs. 

 

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