Gencor has announced the publication of its recent human clinical study investigating its palmitoylethanolamide (PEA) ingredient, Levagen®+, to be a safe, innovative, and effective supplement to ease acute menstrual discomfort.
Menstrual pain, or primary dysmenorrhea (menstrual pain without any underlying pathology), is the most common gynecological condition among women of reproductive age. It is estimated to be the leading cause of chronic pelvic pain globally (World Health Organization). The prevalence rate ranges from 45 to 95% and is linked to restrictions in daily activities, work and school absenteeism, and personal distress.
While the primary mechanisms of dysmenorrhea are not fully understood, the main cause of the painful symptoms is attributed to the overproduction of uterine prostaglandins, particularly prostaglandin F2-α (PGF2α) and prostaglandin E2 (PGE2), which peak during the early days of menstruation. Besides their regulatory effects on inflammation, pain, and body temperature, prostaglandin production is also thought to contribute to secondary symptoms of menstrual pain, such as diarrhea, nausea, and vomiting. Moreover, women experiencing dysmenorrhea may show elevated levels of pro-inflammatory mediators and an increased body temperature.
Preclinical research suggests that PEA’s primary mechanism of action is to provide relief from occasional discomfort and support a balanced inflammatory response, which may be through the activation of peroxisome proliferator-activated receptor-α (PPAR α). Therefore, this study aimed to assess the effectiveness of PEA in alleviating acute menstrual pain in otherwise healthy women.
The randomized, crossover, double-blind, placebo-controlled trial included 80 menstruating females aged 18 years and older self-reporting mild to moderate menstruating cramp pain. Each randomized bottle of the trial product contained either 350mg of Levagen+ or the placebo (350mg of microcrystalline cellulose). Pain scores were recorded on the numerical pain rating scale (NRS) every 30 minutes for up to 4 hours. The findings indicate Levagen+ significantly reduced pain scores compared to placebo at 1, 1.5, 2, and 2.5 hours post-dose, with a pain reduction of approximately 25 percent by 2.5 hours compared to the placebo group. This study demonstrates that Levagen®+ was an effective strategy to reduce acute menstrual pain in healthy women.
“Despite its negative effect on daily life and common occurrence, menstrual pain is often perceived as a ‘normal’ facet of a woman’s menstrual cycle,” said R.V. Venkatesh, Co-Founder and Managing Director at Gencor. “The results of this study show that Levagen®+ can be an effective and quick-acting supplement to support women during their monthly cycles. We are excited to continue to explore how Levagen®+ can support female health.”
To review the published clinical data and for more information on Levagen®+, visit www.levagenplus.com or GencorPacific.com.
