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The main active ingredients of SOYSELECT® are isoflavonoids (such as glucosides) and saponins, both being endowed with several biological properties. The bioavailability of isoflavonoids of SOYSELECT® was markedly improved due tothe presence of saponins.
The short-term efficacy of SOYSELECT® in the treatment of menopausal syndrome was assessed in two randomised, double-blind, placebo-controlled clinical studies in Europe and in the USA. In the European trial (1), 40 postmenopausal women were enrolled and 20 of them received daily 2 x 200 mg of SOYSELECT® (50 mg/die of isoflavones), for six weeks. The results showed that this product was superior to the placebo in reducing the number of hot flushes per week. SOYSELECT® supplementation had no estrogenic effect on the genital tract. The safety and efficacy of SOYSELECT® was confirmed in a second double-blind randomised placebo-controlled study (2). In this multicenter trial, a total of 117 postmenopausal women were randomised to receive either soy extract or a placebo. Once again, SOYSELECT® was effective in reducing the frequency and severity of hot flushes and did not stimulate the endometrium.
SOYSELECT® may be a safe and efficacious therapy for the relief of hot flushes in women who refuse or have contraindications tohormone replacement therapy. This product may indeed be considered highly innovative and Indena has in fact applied for the Italian patent and an international extension in the USA, Japan, Canada and Australia.
(1) G. Scambia et al., Clinical Effects of a Standardized Soy Extract in Postmenopausal Women: A Pilot Study, Menopause, 7: 105-111, 2000
(2) D. H. Upmalis et al., Vasomotor Symptom Relief by Soy Isoflavone Extract Tablets in Postmenopausal Women: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study, Menopause, 7: 236-242, 2000
