P. Mares - Gynaecology Department, Caremeau Hospital, Nîmes, France
S. Palacios - Palacios Institute, Madrid, Spain
B. Pornel - Brussels Menopause Centre, Brussels, Belgium
Aim:
Soya isoflavones are very often used in the treatment of
the menopausal climacteric syndrome. Many Questions have been raised regarding the
safety of these products to the breast and the endometrium. Some clinical studies
have assessed the safety of these isoflavones, but very few studies have been
performed in accordance with international guidelines. This study was conducted in
accordance with the recommendations issued by the European Medicines Agency: evaluation
made on more than 300 women for a minimum of one year.
Protocol:
395 women aged between 45 and 65 were taken into
this multicentre, international, open trial. They were given 70 mg of soya isoflavones
(Phyto Soya®) for 52 weeks. On acceptance into the trial and at the end of it,
an endometrial biopsy, endovaginal echography and mammography were performed. If anyone
left the trial early, the same examinations were carried out when the treatment had
lasted more than 12 weeks.
