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

November 4, 2014 updated by: Rottapharm Spain

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08022
        • Centro Medico Teknon
      • Barcelona, Spain, 08017
        • Somdex S.L.
      • Ciudad Real, Spain, 13004
        • Surgery of Dr. Sánchez Muñoz
      • Madrid, Spain, 28001
        • Gabinete Médico Velázquez
      • Oviedo, Spain, 33004
        • Clínica ginecológica Cecchini
      • Sevilla, Spain, 41003
        • Instituto Sevillano de Ginecología y Obstetricia
      • Valencia, Spain, 46006
        • Surgery of Dr. Mahiques
      • Valencia, Spain, 46006
        • Surgery of Dr. Raga
      • Zaragoza, Spain, 50008
        • Centro Ginecológico Dr. García Pérez-Llantada SL
    • Vizcaya
      • Erandio, Vizcaya, Spain, 48950
        • Grupo hospitalario Quirón

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years to 57 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
isoflavones combined with magnolia
A food supplement containing soy isoflavones, lactobacillus sporogenous, Ca,vitamin D3, magnesium and magnolia extract will be administered once a day during 12 weeks.
Dietary supplement: isoflavones combined with magnolia
1 tablet/day duration: 12 weeks
Other Names:
  • Estromineral Serena

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline, 2, 4, 8 and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rottapharm Spain

Investigators

  • Study Director: Anna Anguera, MD, PhD, Rottapharm S.L.
  • Principal Investigator: Rafael Sánchez-Borrego, MD, Centro Medico Teknon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

March 1, 2013

First Submitted That Met QC Criteria

March 5, 2013

First Posted (Estimate)

March 6, 2013

Study Record Updates

Last Update Posted (Estimate)

November 5, 2014

Last Update Submitted That Met QC Criteria

November 4, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ESTROCALVI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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