Isoflavones and Magnolia Extract in the Quality of Life in Menopausal Women (ESTROCALVI)

Rottapharm

Status: Completed

Conditions: Menopause

Treatments: Dietary Supplement: isoflavones combined with magnolia

Study type: Observational

Funder types: Industry

Identifiers

NCT01805674

ESTROCALVI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 45 to 59 years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

isoflavones combined with magnolia

Description:

A food supplement containing soy isoflavones, lactobacillus sporogenous, Ca,vitamin D3, magnesium and magnolia extract will be administered once a day during 12 weeks.

Treatment:

Dietary Supplement: isoflavones combined with magnolia