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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01805674
Recruitment Status : Completed
First Posted : March 6, 2013
Last Update Posted : November 5, 2014
Information provided by (Responsible Party):
Rottapharm Spain

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.

Condition or disease Intervention/treatment
Menopause Dietary Supplement: isoflavones combined with magnolia

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
Actual Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
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 Start Date : March 2013
Primary Completion Date : July 2013
Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause
U.S. FDA Resources

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 Name: Estromineral Serena

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 59 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01805674

Grupo hospitalario Quirón
Erandio, Vizcaya, Spain, 48950
Somdex S.L.
Barcelona, Spain, 08017
Centro Médico Teknon
Barcelona, Spain, 08022
Surgery of Dr. Sánchez Muñoz
Ciudad Real, Spain, 13004
Gabinete Médico Velazquez
Madrid, Spain, 28001
Clínica ginecológica Cecchini
Oviedo, Spain, 33004
Instituto Sevillano de Ginecología y Obstetricia
Sevilla, Spain, 41003
Surgery of Dr. Mahiques
Valencia, Spain, 46006
Surgery of Dr. Raga
Valencia, Spain, 46006
Centro Ginecológico Dr. García Pérez-Llantada SL
Zaragoza, Spain, 50008
Sponsors and Collaborators
Rottapharm Spain
Study Director: Anna Anguera, MD, PhD Rottapharm S.L.
Principal Investigator: Rafael Sánchez-Borrego, MD Centro Médico Teknon

Responsible Party: Rottapharm Spain
ClinicalTrials.gov Identifier: NCT01805674     History of Changes
Other Study ID Numbers: ESTROCALVI
First Posted: March 6, 2013    Key Record Dates
Last Update Posted: November 5, 2014
Last Verified: November 2014

Keywords provided by Rottapharm Spain:
quality of life
soy isoflavones
magnolia extract