Clinical trial NCT01805674: Isoflavones and Magnolia Extract in the Quality of Life in Menopausal Women
Official title: Study to Evaluate the Changes in Quality of Life in Menopausal Women After the Administration of Soy Isoflavones Combined With Magnolia Extract
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menopause
Keywords: menopause
quality of life
soy isoflavones
magnolia extract
Lead sponsor: Rottapharm Spain
Sponsor class: INDUSTRY
First posted: 2013-03-06
Enrollment: 100
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be conducted in patients with typical mild to mderate vasomotor symptoms and psycho symptoms such as mood changes, or sleep, anxiety / depression, which do not require specific drug treatment.

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.

Eligibility criteria: 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

Primary outcomes:
measure: the quality of life measured by the scale of Cervantes
timeFrame: baseline and 12 weeks
Secondary outcomes:
measure: Clinical changes in vasomotor symptomatology
timeFrame: baseline, 2, 4, 8 and 12 weeks
Other outcomes:
Locations:
city: Erandio
country: Spain
facility: Grupo hospitalario Quirón
state: Vizcaya
city: Barcelona
country: Spain
facility: Somdex S.L.
city: Barcelona
country: Spain
facility: Centro Médico Teknon
city: Ciudad Real
country: Spain
facility: Surgery of Dr. Sánchez Muñoz
city: Madrid
country: Spain
facility: Gabinete Médico Velazquez
city: Oviedo
country: Spain
facility: Clínica ginecológica Cecchini
city: Sevilla
country: Spain
facility: Instituto Sevillano de Ginecología y Obstetricia
city: Valencia
country: Spain
facility: Surgery of Dr. Mahiques
city: Valencia
country: Spain
facility: Surgery of Dr. Raga
city: Zaragoza
country: Spain
facility: Centro Ginecológico Dr. García Pérez-Llantada SL
Study officials:
affiliation: Rottapharm S.L.
name: Anna Anguera, MD, PhD
role: STUDY_DIRECTOR
affiliation: Centro Médico Teknon
name: Rafael Sánchez-Borrego, MD
role: PRINCIPAL_INVESTIGATOR
References: