An observational study in Menopause, sponsored by Rottapharm Spain. Completed at 10 sites in Spain. Open to female participants aged 45 Years to 59 Years. Per ClinicalTrials.gov, last updated 2014-11-05.
Sponsored by Rottapharm Spain · Observational
In menopause, the vasomotor symptomatology, accompanied or less by affective and behavioural symptoms, globally worsens the quality of daily life.
The improvement of the quality could be reached with adequate food supplements, named phytoestrogens, in particular Soy Isoflavones (SI), which are natural substances with estrogen-like and estrogen-antagonistic activity, which are active in the control of menopausal vasomotor symptoms. Besides, combined with magnolia extract it could improve the psychological symptomatology also improving the quality of life.
Multicenter, observational, prospective, longitudinal study of clinical practice conducted in 10 gynecological centers.
The study will be conducted in patients with typical mild to moderate vasomotor symptoms and psycho symptoms such as mood disorders, or sleep, anxiety / depression, which do not require specific drug treatment.
Quality of life will be analyzed by the scale of Cervantes.
Rottapharm Spain is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study will be conducted in patients with typical mild to mderate vasomotor symptoms and psycho symptoms such as mood changes, or sleep, anxiety / depression, which do not require specific drug treatment.
Exclusion Criteria:
A food supplement containing soy isoflavones, lactobacillus sporogenous, Ca,vitamin D3, magnesium and magnolia extract will be administered once a day during 12 weeks.
Dietary Supplement: isoflavones combined with magnolia
1 tablet/day duration: 12 weeks
Also known as: Estromineral Serena
the quality of life measured by the scale of Cervantes
The Cervantes scale is a Spanish validated questionnaire specific for measure the quality of life in menopausal women
Time frame: baseline and 12 weeks
Clinical changes in vasomotor symptomatology
In a semiquantitative scale of intensity the vasomotor, psychological and sexual symptomatology will be evaluated in each visit
Time frame: baseline, 2, 4, 8 and 12 weeks
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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Rottapharm Spain