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Menopause

Menopause is a normal, natural process, but that this process comes with unpleasant symptoms such as hot flashes, changes to cognitive performance, and sleep disruptions. Decades of pharmaceutical drug failures have pushed more and more women seeking solutions into the natural products realm. 

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Sales of menopausal-related supplements reveal that these consumers are willing to invest in companies that bring proof. A clinical trial with Nutraceuticals Research Institute can deliver the evidence your brand needs to stand out in this crowded market. 

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To measure menopausal support, including symptoms such as hot flashes or dry skin, our team utilizes the Franklin Health Menopause Symptom Scale (FHMSS). This comprehensive tool is capable of capturing the myriad of symptoms associated with menopause. It includes vasomotor symptoms, pain, sexual health, cognition, skin health, sleep, and self-image, delivering a comprehensive and holistic view of menopausal symptoms. This not only accurately captures your products effects on menopausal symptoms, it pinpoints exactly where your products greatest effects are seen. 

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A natural products menopause-related trial at Nutraceuticals Research Institute will typically focus on 7 - 8 key endpoints. Each product has unique needs, so your trial's specific endpoints will be determined through collaboration between your marketing goals and our research team, ensuring that they match your product's greatest effects. Our most commonly used endpoints include: 

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PAIN & DISCOMFORT

Physical symptoms ranging from achy neck to sore knees are all captured on the pain and discomfort subdomain.

VASOMOTOR

Vasomotor symptoms such as hot flashes or night sweats are common menopausal complaints, and targeting these symptoms is a priority for many women. 

SEXUAL HEALTH

The sexual health domain captures improvements to symptoms such as libido and vaginal dryness.  

COGNITION

The cognition domain captures improvements to memory, loss of concentration, and cognitive fatigue. 

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Skin Health

The skin subdomain of the menopause scale captures improvements to menopause-induced dermal symptoms such as dull, dry, or thin skin. 

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Self Image

As symptoms subside, holistic menopausal improvements include changes to confidence levels, optimism, and self efficacy–all of which are captured in this subdomain. 

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SLEEP

The menopause symptoms sleep domain captures improvements to symptoms such as difficulty falling asleep and daytime fatigue. 

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LABWORK

Biomarkers such as estriol, estradiol, estrone, or TSH all serve as proxy measurements to identify changes to the body that can be attributed to your product. 

Menopause Clinical Trials

Menopause is a highly individualized and complex process. Unlike simplistic lab-related outcomes, such as blood pressure or cholesterol, menopausal symptoms reflect a complex combination of both physical and psychological factors. Studying a product's effects on this lengthy transition period involves addressing a wide range of individual effects.

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Working with Nutraceuticals Research Institute for a high quality clinical trial for a menopausal product is a worthwhile investment as these studies have the potential to substantiate claims such as: 

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  • reduces hot flashes 

  • improves sleep quality during menopause 

  • supportive for menopausal women 

  • alleviates menopausal-induced stress

  • supports healthy sexual health during menopause 

 

Products that target symptoms of menopause typically benefit from a single primary outcome of menopausal symptoms, which may be measured through our comprehensive scale or one of our sub-scales. Additional claims, such as sleep, stress, or mood, can be comprehensively included as secondary outcomes. 

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