Clinical summary

Preclinical Studies

Study 1 was conducted in a murine menopausal model to demonstrate beneficial effect of Warmi® and compared with placebo effect, by preventing body and uterine weight gain, and decreasing triglyceride and total cholesterol levels.

Clinical Studies

Study 2 was a Phase-1, double-blinded, placebo-controlled, randomized clinical trial (RCT). Number of subjects was 60 women and study duration was for 3 months.

This Phase-1 study results confirmed that the daily consumption of Warmi® was safe and tolerable in healthy adult women. Moreover, no negative effect either on menstrual cycles, or on serum hormonal profile (Estradiol, LH, FSH and progesterone), or on body mass index, or on blood pressure values was observed.

Study 3 was a Phase-2 single blinded, three-armed controlled, randomized clinical trial against available marketed popular HRT (i.e., Tibolone®). This Phase-2 study concluded that the decrease of baseline menopausal symptoms (MENQOL) after three months of treatment was significant in all three groups (two doses of Warmi® (low & high) and marketed HRT) without difference between the groups. Number of subjects in this study was 60 women and the study duration was also for 3 months.

Study 4 was a double-blinded randomized clinical trial, comparing Warmi® against available marketed popular HRT (i.e., Tibolone®) and placebo.  Number of subjects was 60 women and duration of the study was again 3 months.

Study 5 was a double-blinded randomized clinical trial, comparing Warmi® against available marketed popular HRT (i.e., Tibolone®) and Isoflavones. Number of subjects was 60 women, duration of study was again 3 months.

Both the studies (# 4 & #5) results consistently found that oral administration of Warmi® for six months significantly improved levels of total blood cholesterol (decreased), LDL (decreased), HDL (increased), estradiol, and IL-6. In addition, the RCT study which compared Warmi® against Tibolone® and Placebo found significant improvements in the LDL/HDL ratio and levels of osteocalcin and IL-8, as well as the alleviation of all common menopausal (as per Green Climacteric Scale) and sexuality symptoms (as per McCoy Scale).

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