Extrait

Background and study aims The menopause happens when a woman stops having periods and is no longer able to get pregnant naturally. Symptoms can include hot flushes, low mood or anxiety, reduced sex drive and problems with memory and concentration. It can also increase the risk of developing osteoporosis, a condition where the bones become weaker and more likely to break. This study investigates whether a food supplement can alleviate the symptoms of the menopause and reduce the likelihood of developing osteoporosis. Who can participate? Women aged between 50-55 and going through the menopause. What does the study involve? Participants are randomly allocated to one of two groups. Those in group 1 are given the active food supplement. Those in group 2 are given a placebo (dummy pill). Markers that show whether the participant is at risk of developing osteoporosis are measured for all participats before treatment begins, 6 months after treatment and again after 12 months. What are the possible benefits and risks of participating? Not provided at time of registration Where is the study run from? Farcoderm Srl, San Martino Siccomario (Italy) When is the study starting and how long is it expected to run for? April 2011 to May 2012 Who is funding the study? Paladin Pharma S.p.A. Who is the main contact? Dr Nobile Vincenzo [email protected]

Critère d'inclusion

• Menopause and bone turnover

Liens

• isrctn
• ictrp