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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rottapharm Spain
ClinicalTrials.gov Identifier:
NCT01805674
First received: March 1, 2013
Last updated: November 4, 2014
Last verified: November 2014
  Purpose

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 Intervention
Menopause
Dietary Supplement: isoflavones combined with magnolia

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Rottapharm Spain:

Primary Outcome Measures:
  • the quality of life measured by the scale of Cervantes [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
    The Cervantes scale is a Spanish validated questionnaire specific for measure the quality of life in menopausal women


Secondary Outcome Measures:
  • Clinical changes in vasomotor symptomatology [ Time Frame: baseline, 2, 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
    In a semiquantitative scale of intensity the vasomotor, psychological and sexual symptomatology will be evaluated in each visit


Enrollment: 100
Study Start Date: March 2013
Study Completion Date: October 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

Ages Eligible for Study:   45 Years to 59 Years
Genders 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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01805674

Locations
Spain
Grupo hospitalario Quirón
Erandio, Vizcaya, Spain, 48950
Centro Médico Teknon
Barcelona, Spain, 08022
Somdex S.L.
Barcelona, Spain, 08017
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
Investigators
Study Director: Anna Anguera, MD, PhD Rottapharm S.L.
Principal Investigator: Rafael Sánchez-Borrego, MD Centro Médico Teknon
  More Information

No publications provided

Responsible Party: Rottapharm Spain
ClinicalTrials.gov Identifier: NCT01805674     History of Changes
Other Study ID Numbers: ESTROCALVI
Study First Received: March 1, 2013
Last Updated: November 4, 2014
Health Authority: Spain: Ethics Committee

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

ClinicalTrials.gov processed this record on November 24, 2014