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

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.

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Key information

Conditions

Menopause

Age range

45 year–59 year

Sex eligibility

Female

Study type

Observational

Primary location

Centro Médico Teknon, Barcelona, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

isoflavones combined with magnolia

Dietary Supplement

1 tablet/day duration: 12 weeks

Other names: Estromineral Serena

Primary outcomes

the quality of life measured by the scale of Cervantes

Time frame: baseline and 12 weeks

The Cervantes scale is a Spanish validated questionnaire specific for measure the quality of life in menopausal women

Secondary outcomes

Clinical changes in vasomotor symptomatology

Time frame: 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

Sponsors and collaborators

Lead sponsor

Rottapharm Spain

Industry

Registry information

Official study title

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

Acronym: ESTROCALVI

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Mar 6, 2013
Registry last updated: Nov 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed