Isoflavones and Magnolia Extract in the Quality of Life in Menopausal Women (ESTROCALVI)
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Study to Evaluate the Changes in Quality of Life in Menopausal Women After the Administration of Soy Isoflavones Combined With Magnolia Extract|
- the quality of life measured by the scale of Cervantes [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]The Cervantes scale is a Spanish validated questionnaire specific for measure the quality of life in menopausal women
- Clinical changes in vasomotor symptomatology [ Time Frame: baseline, 2, 4, 8 and 12 weeks ] [ Designated as safety issue: No ]In a semiquantitative scale of intensity the vasomotor, psychological and sexual symptomatology will be evaluated in each visit
|Study Start Date:||March 2013|
|Study Completion Date:||October 2013|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
isoflavones combined with magnolia
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
Other Name: Estromineral Serena
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01805674
|Grupo hospitalario Quirón|
|Erandio, Vizcaya, Spain, 48950|
|Barcelona, Spain, 08017|
|Centro Médico Teknon|
|Barcelona, Spain, 08022|
|Surgery of Dr. Sánchez Muñoz|
|Ciudad Real, Spain, 13004|
|Gabinete Médico Velazquez|
|Madrid, Spain, 28001|
|Clínica ginecológica Cecchini|
|Oviedo, Spain, 33004|
|Instituto Sevillano de Ginecología y Obstetricia|
|Sevilla, Spain, 41003|
|Surgery of Dr. Mahiques|
|Valencia, Spain, 46006|
|Surgery of Dr. Raga|
|Valencia, Spain, 46006|
|Centro Ginecológico Dr. García Pérez-Llantada SL|
|Zaragoza, Spain, 50008|
|Study Director:||Anna Anguera, MD, PhD||Rottapharm S.L.|
|Principal Investigator:||Rafael Sánchez-Borrego, MD||Centro Médico Teknon|