Menopause
Conditions
Keywords
menopause, quality of life, soy isoflavones, magnolia extract
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTisoflavones combined with magnolia
1 tablet/day duration: 12 weeks
Sponsors
Rottapharm Spain
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 59 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the quality of life measured by the scale of Cervantes | baseline and 12 weeks | The Cervantes scale is a Spanish validated questionnaire specific for measure the quality of life in menopausal women |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical changes in vasomotor symptomatology | baseline, 2, 4, 8 and 12 weeks | In a semiquantitative scale of intensity the vasomotor, psychological and sexual symptomatology will be evaluated in each visit |
Countries
Spain
Outcome results
None listed