(P03-068-23) Safety Evaluation of a Novel Botanical Blend for the Treatment of Hot Flash-like Symptoms in Ovariectomized Rats

Objectives: A common symptom of menopause experienced by women are vasomotor symptoms (VMS) such as hot flashes and night sweats. While hormone replacement therapy (HRT) has been the most effective treatment for menopausal VMS to date, many women seek non-hormonal, natural treatment alternatives. VMS is caused by a loss of thermoregulatory control, which is impacted by the NKB pathway, and specifically the NK3 receptor. Recent studies have reported that there is a relationship between neurokinin 3 (NK3) receptor signals and VMS associated with menopause. VMS-BH02 is a proprietary natural botanical blend formulated to reduce VMS through this novel pathway. The current study was conducted to investigate the safety of VMS-BH02 on female hormone profile and liver and kidney function in ovariectomized rats.

Methods: Female Sprague-Dawley rats (8 weeks old; 6 rats in each group) were divided into three groups: sham-operated control, ovariectomized (OVX) untreated, and OVX + VMS-BH02 treated. Vehicle or VMS-BH02 was administered orally for 8 days. On day 8 of repeated administration, tail, core, and skin temperatures were measured every 30 minutes for 24 hours. Approximately 2 hours after the final administration, blood samples were collected.

Results: Decreases in uterine weight, serum estradiol, and progesterone levels, and increases in luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels and tail temperature were detected in ovariectomized rats (p < 0.0001 for all). Oral administration of VMS-BH02 decreased FSH (p=0.005) and LH (p=0.031) levels and alleviated hot flash-like symptoms but did not affect body and uterine weights, serum estradiol, and progesterone levels (p >0.05). In addition, no treatment-related changes in liver and kidney functions, no gross lesions, and no changes in histopathology were observed.

Conclusions: This study confirmed the safety of VMS-BH02 on female hormone profile and liver and kidney function. VMS-BH02 treatment did not increase uterine weight or estradiol levels compared to the ovariectomized control. These findings provide support for the safety of this combination in a menopausal population. Future clinical studies in women will be conducted to further confirm these results.

Funding Sources: This study was funded by Bonafide Health, LLC. USA.