Menopause, although a natural phenomena in a woman’s life, is very often accompanied by disturbing side effects in the form of vasomotor, psychological and metabolic complaints, as well as significant health issues such as cardiovascular diseases and bone loss leading to osteopenia and osteoporosis.

The recent barrage of publications pointing to increased health risks associated with hormone therapy has caused an upheaval in the women's health sector. As a result, a large gap has opened up in the provision of safe solutions for the integrative therapy of menopausal symptoms and bone health (osteopenia).

The essential requirements for a therapy are focused today on two levels.

· Efficacy: A solution that effectively manages the menopause transition by providing relief of menopausal symptoms while treating osteopenia.

· Safety: Use of recognized safety markers that serve as a warning for increased risk factors, thus providing a treatment option that is safe both in the short and in the long term.

Slowing the process of bone loss while alleviating menopausal symptoms requires a therapy that targets the physiological mechanisms affected by estrogen. For such a therapy to be safe, however, it must be selective.

The ultimate therapeutic concept for fulfilling these needs is a novel Selective Estrogen Receptor Modulator (SERM) that affects estrogen receptors only in specific sites, without affecting tissues where any change can have dangerous consequences.

Femarelle^® (DT56a) is a product based on this concept.

Clinical and pre-clinical studies have shown that Femarelle^® exerts agonistic (stimulatory) activity on the estrogen receptors that control menopausal symptoms and the process of bone build-up, while having an antagonistic (blocking) effect on estrogen receptors in the breast and the uterus. In other words, Femarelle^® acts as a novel SERM.

The results of the above mentioned studies clearly show and prove that Femarelle^® successfully meets both the efficacy and safety requirements, and thus provides women with a safe and effective integrative solution for the relief of menopausal symptoms and the treatment of osteopenia.