The effects of Femarelle^® were assessed on a wide variety of menopause-related symptoms.

In a clinical trial, healthy post-menopausal women (n=80) were randomly allocated to receive either the standard dose (2 capsules/day) or a low dose of Femarelle^®. A detailed medical history was taken from each participant upon enrollment, and this was followed by a physical examination, pelvic ultrasound, and recording of blood tests looking at the effect of Femarelle^® on the different organs. Each patient completed a detailed menopausal symptoms questionnaire. The hormonal blood profile, endometrial thickness, and breast tissue in all patients were monitored. These procedures were repeated every 3 months during the 12 months of the study.

Results

Efficacy

Femarelle^® achieved a significant reduction in menopausal symptoms, which was sustained throughout the 12 months of treatment.

Efficacy of Femarelle^® Treatment

Safety

There were no changes in the endometrial thickness or in the breast tissue. The sex hormones estradiol (E₂) and follicle-stimulating hormone (FSH) remained unchanged. Furthermore, the thyroid-stimulating hormone, the liver and kidney functions remained the same. Femarelle^® did not cause endometrial bleeding and there were no reported side effects.

Safety of Femarelle^® Treatment

Conclusion

Femarelle^® significantly alleviated menopausal symptoms in about 75% of the patients without affecting endometrial thickness or hormonal blood profiles. The lack of change in hormonal levels showed that the body does not recognize Femarelle^® as estrogen, despite the fact that it affects estrogen receptors in designated sites.

Publication

J. of Clinical & Experimental Obstetrics & Gynecology 2004; 31(2): 123-126: "Efficacy and Safety of Standard versus Low Dose of Femarelle (Tofupill) for the Treatment of Menopausal Symptoms"; I. Yoles et al