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

Rottapharm Spain100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Menopause

Interventions

isoflavones combined with magnoliaDIETARY_SUPPLEMENT

1 tablet/day duration: 12 weeks

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 59 Years

Medical Language ↔ Plain English

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

Locations (10)

Somdex S.L.

Barcelona, Barcelona, Spain

Centro Médico Teknon

Barcelona, Barcelona, Spain

Surgery of Dr. Sánchez Muñoz

Ciudad Real, Ciudad Real, Spain

Gabinete Médico Velazquez

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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