Isoflavones and Magnolia Extract in the Quality of Life in Menopausal Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Study to Evaluate the Changes in Quality of Life in Menopausal Women After the Administration of Soy Isoflavones Combined With Magnolia Extract

Conditions
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Menopause

Intervention / Treatment
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* Dietary Supplement: isoflavones combined with magnolia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with at least 12 months of amenorrhea Presence of 1 or more vasomotor symptoms as hot flushing, nocturnal sweating or palpitations One or more psychological symptoms as insomnia, irritability, anxiety, depressed mood. Also with concomitant symptoms of sexual area as reduction of libido and vaginal dryness. Women must give the informed consent Exclusion Criteria: clinical history of medical or surgical pathologies that could affect the results of the study, including serious cardiovascular, metabolic, kidney or liver diseases Patients with the habit of eating soy foods or dietary supplements with soy extract patients diagnosed with breast or uterine mass (neoplasia hormone sensitive) patients that were treated with estrogens (HRT or phytoestrogens)in the 2 months before the beginning of the study. patients with treatment with antibiotics, antidepressant and/or anxiolytic products

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| isoflavones combined with magnolia<br>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<br>* 1 tablet/day duration: 12 weeks<br>* Other names: Estromineral Serena;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical changes in vasomotor symptomatology | In a semiquantitative scale of intensity the vasomotor, psychological and sexual symptomatology will be evaluated in each visit | baseline, 2, 4, 8 and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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menopause, quality of life, soy isoflavones, magnolia extract