(P22-001-25) The Effects of a Non-Hormonal NK3R Antagonist Nutritional Supplement on Joint Discomfort and Quality of Life Parameters in Peri- and Postmenopausal Females

Objectives: To evaluate the efficacy of Thermella®, a novel non-hormonal neurokinin 3 receptor (NK3R) antagonist nutritional supplement, in ameliorating joint discomfort and improving quality of life (QoL) metrics in healthy, peri- and postmenopausal females 40-70 years of age reporting joint discomfort.

Methods: This interim analysis reports findings from an ongoing 12-week open-label clinical trial. The analysis includes data from participants who completed the initial 4 weeks of daily Thermella® supplementation. Efficacy was assessed using a modified Musculoskeletal Health Questionnaire (mMSK-HQ) and visual analog scales (VAS) for joint discomfort. Primary endpoints include change in joint discomfort severity and QoL metrics from baseline to week 4. Descriptive data (symptom severity) were transformed to numerical values for statistical analysis. Data were analyzed using Group x Time Repeated Measures ANOVA (𝞪 < 0.05).

Results: The study cohort (n=108, 56.0 ± 6.2 yrs) demonstrated statistically significant improvements in joint discomfort parameters and QoL after 4 weeks of consuming Thermella®. The mMSK-HQ outcomes include a 35% reduction in joint discomfort severity (p < 0.001), with a 73% response rate. Additionally, in participants reporting moderate to severe joint discomfort at baseline (n=58), 71% (n=32) improved to none or mild discomfort by week 4. QoL metrics related to joint discomfort improved by 40% (p < 0.001), with a 56% response rate. VAS scores for joint discomfort showed a 37% reduction (p < 0.001), with an 81% response rate. Additionally, 24% of participants reported complete resolution of joint discomfort by week 4.

Conclusions: The results from this interim analysis in an open-label trial suggest that Thermella®, a non-hormonal NK3R antagonist nutritional supplement, significantly reduces joint discomfort and improves QoL metrics in peri- and postmenopausal females within 4 weeks of supplementation. While these initial results are promising, the ongoing 12-week assessment and future double-blind, placebo-controlled trials will be essential to validate the efficacy and safety of response. These data provide a foundation for further investigation of NK3R antagonism as a therapeutic strategy for managing multiple menopausal symptoms.

Funding Sources: Bonafide Health, LLC